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Difluprednate

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Difluprednate does in the body

From the FDA-approved label: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing.

They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

Why people take it. Inflammation and pain associated with ocular surgery

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · S8A06QG2QE · read 2026-08-29

  • Its recorded molecular formula is C27H34F2O7, weighing 508.55 g/mol.

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

No statement of the main limit is recorded.

The four opening statements run to 92 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Seroconversion rates (A/H1N1, A/H3N2, and B)

The study did not show it

Who was studied
NCT02215863
How many people
1195
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks

The study did not show it

Who was studied
NCT01276223
How many people
722
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Best Spectacle-Corrected Visual Acuity

The study did not show it

Who was studied
NCT04097730
How many people
280
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change from baseline corneal thickness between treatments

The study did not show it

Who was studied
NCT04631315
How many people
255
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).

The study did not show it

Who was studied
NCT00430092
How many people
219
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).

The study did not show it

Who was studied
NCT00429923
How many people
219
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: The treatment of inflammation and pain associated with ocular surgery (1.1) The treatment of endogenous anterior uveitis (1.2) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Difluprednate was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery.”

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

  • On older people, the label states: “No overall differences in safety or effectiveness have been observed between elderly and younger patients.”

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of difluprednate in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of difluprednate to an infant during lactation.”

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Ophthalmic

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as emulsion, given by the ophthalmic route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Difluprednate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 286 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • intraocular pressure increased — 66 reaction mentions
  • vision blurred — 42 reaction mentions
  • eye pain — 35 reaction mentions
  • visual impairment — 33 reaction mentions
  • eye irritation — 32 reaction mentions
  • cataract — 18 reaction mentions
  • eye inflammation — 16 reaction mentions
  • visual acuity reduced — 16 reaction mentions
  • ocular hyperaemia — 15 reaction mentions
  • corneal oedema — 13 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Ophthalmic

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.

    FDA National Drug Code directory · 0832-6054 · read 2026-08-29

  • They are sold as emulsion and powder, taken ophthalmic.

    FDA National Drug Code directory · 0832-6054 · read 2026-08-29

  • 10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-29

  • Difluprednate is ophthalmic at 3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing 0.05% difluprednate., recorded as fda label in effect 2026-04-09 in the United States.

    US prescribing information · 3612ff2a-c4bf-4322-b5bc-e7b867575321 · read 2026-08-30

  • Recorded price in US: 8.91843 USD per one millilitre, across 8 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Difluprednate studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Difluprednate are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
S8A06QG2QE
RxNorm concept
804544

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 9 approved applications cover products containing this substance. The earliest was NDA022212, approved 20080623 to SANDOZ.

    Drugs@FDA application register · NDA022212 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA022212 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20110125.

    FDA National Drug Code directory · 0832-6054 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

8 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

What did Difluprednate's largest trial (722 people) and its longest (4 years) measure?


722 people in Difluprednate's largest registered study, 4 years in its longest registered window, measuring The anterior chamber cell score was compared between baseline and after completion of the. ClinicalTrials.gov · 2026-09-01

13 phase3, 4 phase2, 3 phase4; NCT04097730; 2024-09-18; no ageing endpoint recorded. Last human test completed 2024, NCT04097730.

Interpretation These counts include studies where Difluprednate was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase3
    13
  • phase2
    4
  • phase4
    3
  • Last recorded human test NCT04097730
    2024-09-18

recorded 2026-09-01 · last checked 2026-09-04

Difluprednate was tested only in human — what did it show?


human: mechanism-only (20): the rungs where Difluprednate has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation The anterior chamber cell score was compared between baseline and after completion of the — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human mechanism-only
Show the evidence
  • human NCT00405496
    mechanism-only; The anterior chamber cell score was compared between baseline and after completion of the; 20

recorded 2026-09-01 · last checked 2026-09-04

2 of Difluprednate's trials stopped: accrual/recruitment?


accrual/recruitment (2): Difluprednate's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Difficulty enrolling"; 2 of 20 registered studies

Show the evidence

Trial

  • NCT01939691
    terminated; "Difficulty enrolling"
  • NCT04687800
    terminated; "Inability to enroll due to lack of access to the Ambulatory Surgery Center."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Difluprednate used Difluprednate ophthalmic emulsion, 0.05% — over how long?


Human studies of Difluprednate used "Difluprednate ophthalmic emulsion, 0.05%". ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; ophthalmic; also "Difluprednate 0.05% ophthalmic emulsion", "Difluprednate ophthalmic emulsion 0.05%", "Difluprednate 0.05%"

Show the evidence

human

  • NCT01124045
    ophthalmic; Difluprednate ophthalmic emulsion, 0.05%
  • NCT01201798
    ophthalmic; Difluprednate 0.05% ophthalmic emulsion
  • NCT01244334
    ophthalmic; Difluprednate ophthalmic emulsion 0.05%
  • NCT03693989
    Difluprednate 0.05%
  • NCT04687800
    Durezol 0.05% Ophthalmic Emulsion

recorded 2026-09-01 · last checked 2026-09-04

Could one person measure Difluprednate's effect on an anterior cell grade of 0 at day 15 2 days?


An anterior cell grade of 0 at day 15 2 days: measured in Difluprednate's trials.

an anterior cell grade of 0 at day 15 2 days is the recorded endpoint.

Show the evidence

biomarkers

  • an anterior cell grade of 0 at day 15 2 days; 2026-09-01
  • anterior chamber cell grade at day 14; 2026-09-01
  • central subfield thickness; 2026-09-01
  • adverse events; 2026-09-01
  • best spectacle corrected visual acuity; 2026-09-01
  • intraocular pressure from baseline; 2026-09-01
  • human trials at or under30
    6
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    1; NCT04687800; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; TERMINATED

Which of adverse events, an anterior cell grade of 0 at day 15 2 days and anterior chamber cell grade at day 14 did Difluprednate's trials measure?


adverse events, an anterior cell grade of 0 at day 15 2 days and anterior chamber cell grade at day 14 lead 6 outcome terms across Difluprednate's trials. ClinicalTrials.gov · 2026-09-01

Interpretation adverse events, best spectacle corrected visual acuity and intraocular pressure from baseline follow.

Show the evidence
  • an anterior cell grade of 0 at day 15 2 days
    1
  • anterior chamber cell grade at day 14
    1
  • central subfield thickness
    1
  • adverse events
    1
  • best spectacle corrected visual acuity
    1
  • intraocular pressure from baseline
    1

recorded 2026-09-01 · last checked 2026-09-04

What will the one ongoing trial of Difluprednate report, and when?


1 registered trial of Difluprednate is open; earliest completion 2027-02-28. ClinicalTrials.gov · 2026-09-01

Interpretation Best Spectacle-Corrected Visual Acuity

Show the evidence
  • Trial NCT06271772
    "Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II"; n 60; "Best Spectacle-Corrected Visual Acuity"; 2027-02-28

recorded 2026-09-01 · last checked 2026-09-04

Which 9 trials of Difluprednate posted no result?


Posted no result
9 of 9 completed trials
Registrations
NCT00407225, NCT00405496, NCT00407056, NCT00406497, NCT00406887 and NCT00406341, and 3 more
Completion dates
oldest 2000-10; newest 2010-11
Show the evidence

Trial

  • NCT00407225
    2000-10
  • NCT00405496
    2001-04
  • NCT00407056
    2003-06
  • NCT00406497
    2003-07
  • NCT00406887
    2003-11
  • NCT00406341
    2005-03
3 further recorded trials
  • NCT00616070
    2008-03
  • NCT00616993
    2008-03
  • NCT01244334
    2010-11

At the median, Difluprednate's trials enrolled 111 people — anything larger?


Median enrolment
111
Largest enrolment
722
Registered trials counted
19

What do 286 spontaneous reports say about Difluprednate — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Difluprednate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 286 reaction mentions were counted: intraocular pressure increased 66; vision blurred 42; eye pain 35; visual impairment 33. open-targets-adr · CHEMBL1201749 · 2026-06-24

Show the evidence
  • intraocular pressure increased
    66
  • vision blurred
    42
  • eye pain
    35
  • visual impairment
    33
  • eye irritation
    32
  • cataract
    18
4 more recorded rows
  • eye inflammation
    16
  • visual acuity reduced
    16
  • ocular hyperaemia
    15
  • corneal oedema
    13

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201749
PubChem CID
443936
CAS number
23674-86-4
RxCUI
23043
InChIKey
WYQPLTPSGFELIB-JTQPXKBDSA-N
Also called
Difluprednato, 6α,9-Difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate, DIFLUPREDNATE [JAN], DIFLUPREDNATE [MART.], DIFLUPREDNATE [MI], DIFLUPREDNATE [ORANGE BOOK], DIFLUPREDNATE [USAN], DIFLUPREDNATE [VANDF], Difluprednate [WHO-DD]
Trade name
Durezol, Difluprednate Ophthalmic Emulsion, Durezol / Difluprednate Ophthalmic Emulsion
Development code
W 6309
Salt form
DIFLUPREDNATE OPHTHALMIC
Sources (7)

Sources

1 more source

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.