CClinicalTrials.gg
Sign In
CompletedNCT00429923Updated Jul 2, 2009Results posted

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)

A Phase 3 interventional study of Difluprednate and Difluprednate in Inflammation, sponsored by Sirion Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2009-07-02.

Sponsored by Sirion Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
219
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.

02

Conditions studied

  • Inflammation

Browse trials for

03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 219 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Sirion Therapeutics, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All

Eligibility criteria

Inclusion Criteria:

  • Unilateral ocular surgery in the day prior to study enrollment.
  • Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
  • Aged 2 years or older on the day of consent.
  • Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
  • Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.

Presurgical Exclusion Criteria:

  • Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
  • Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
  • Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
  • Any history of glaucoma or ocular hypertension in the study eye.
  • History or presence of endogenous uveitis.
  • Any current corneal abrasion or ulceration.
  • Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
  • Allergy to similar drugs, such as other corticosteroids.
  • History of steroid-related IOP increase.
  • Scheduled surgery on the contralateral eye during the treatment period.
  • Unwilling to discontinue use of contact lenses during the study period.
  • Pregnancy or lactation.
  • Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
  • Prior participation in the study described in this protocol.
  • Unable or unwilling to give signed informed consent prior to participation in any study related procedures.

Postsurgical Exclusion Criteria:

  • Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
  • Injection of gas into the vitreous body during surgery.
  • Presence of IOP ≥24 mm Hg on Day 1 after surgery.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
219 participants (actual)

Study arms

  • Experimental
    Difluprednate 0.05% BID

    Difluprednate 0.05% 1 drop BID for 14 days.

    Drug: Difluprednate

  • Experimental
    Difluprednate 0.05% QID

    Difluprednate 0.05% 1 drop QID for 14 days.

    Drug: Difluprednate

  • Placebo comparator
    Placebo

    Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.

    Drug: Placebo

Interventions

  • DrugDifluprednate
  • DrugDifluprednate
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.

    Time frame: Day 8 (QID)

07

Results

Posted Jul 2, 2009

Participant flow

First subject enrolled February 6, 2007 and last subject completed September 17, 2007 at 13 sites in the United States.

Participant flow — Overall Study
MilestoneDifluprednate 0.05% BIDDifluprednate 0.05% QIDPlacebo
Started5755107
Completed525168
Not completed5439
Withdrew: Adverse event023
Withdrew: Lack of efficacy4133
Withdrew: Lost to follow-up002
Withdrew: Withdrew consent101
Withdrew: Early termination010

Outcome measures

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

Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.

Time frame:
Day 8 (QID)
Reported as:
Number · participants
Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).
participantsDifluprednate 0.05% BIDDifluprednate 0.05% QIDPlacebo
Proportion of subjects w/AC cell grade=0 on Day 801913
Statistical analysis
  • Difluprednate 0.05% QID vs Placebo · Mantel Haenszel · p = 0.0014

Baseline characteristics

Age Continuous
Age Continuous(years)Difluprednate 0.05% BIDDifluprednate 0.05% QIDPlaceboTotal
Mean70.8 ± 068.1 ± 069.1 ± 069.3 ± 0
Sex: Female, Male
Sex: Female, Male(Participants)Difluprednate 0.05% BIDDifluprednate 0.05% QIDPlaceboTotal
Female303151112.0
Male272456107.0
08

Study locations

1 site
  • Comprehensive Eye Care
    Washington, Missouri 63090, United States
09

References and documents

Publications

  • Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024. PubMed 19101421 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00429923
Lead sponsor
Sirion Therapeutics, Inc.
First posted
Feb 1, 2007
Results posted
Jul 2, 2009
Last update
Jul 2, 2009

Study contacts

Roger Vogel, MD
study chair · Sirion Therapeutics, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Inflammation→

Other studies from this sponsor

Sirion Therapeutics, Inc.

Start the discussion