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

NCT00429923 | Completed Phase 3 Results

• 1 other identifier: ST-601A-002a
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation

Outcome Measures

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.

  Day 8 (QID)

Study Arms (3)

Difluprednate 0.05% BID

EXPERIMENTAL

Difluprednate 0.05% 1 drop BID for 14 days.

Drug: Difluprednate

Difluprednate 0.05% QID

EXPERIMENTAL

Difluprednate 0.05% 1 drop QID for 14 days.

Drug: Difluprednate

Placebo

PLACEBO COMPARATOR

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

Difluprednate DRUG

Difluprednate 0.05% BID

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirion Therapeutics, Inc.: lead

Study Sites (1)

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

Related Publications (1)

• 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.

  PMID: 19101421 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

difluprednate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jeremy Brace
• Organization: Sirion Therapeutics, Inc.

jbrace@siriontherapeutics.com

813-496-7325

Study Officials

• Roger Vogel, MD

  Sirion Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Last Updated: July 2, 2009
• Results First Posted: July 2, 2009

Record last verified: 2009-05

Locations

US (1)