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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429923
Recruitment Status : Completed
First Posted : February 1, 2007
Results First Posted : July 2, 2009
Last Update Posted : July 2, 2009
Information provided by:
Sirion Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Inflammation Drug: Difluprednate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). [ Time Frame: Day 8 (QID) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429923

United States, Missouri
Comprehensive Eye Care
Washington, Missouri, United States, 63090
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Study Chair: Roger Vogel, MD Sirion Therapeutics, Inc.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00429923     History of Changes
Other Study ID Numbers: ST-601A-002a
First Posted: February 1, 2007    Key Record Dates
Results First Posted: July 2, 2009
Last Update Posted: July 2, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents