Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Phase 3

Completed

• Conditions: Anterior Uveitis; Panuveitis

• Registration Number: NCT00406887
• Lead Sponsor: Sirion Therapeutics, Inc.

Brief Summary

The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.

Detailed Description

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

Study Timeline

• Study Start: 2002-08
• Study Completion: 2003-11
• Status Verified: 2006-11
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Last Update Submitted: 2006-11-29
• Study First Posted: 2006-12-04
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients diagnosed with endogenous anterior uveitis or panuveitis
• Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
• Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
• Patients provided written informed consent prior to initiation of the study

Exclusion Criteria

• Patients who did not meet all of the above inclusion criteria
• Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
• Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
• Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
• Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
• Patients with glaucoma or ocular hypertension
• Patients with corneal abrasion or ulcer
• Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
• Patients with allergy to similar drugs such as other corticosteroids
• Patients requiring use of contact lens during the study period
• Women who are or might be pregnant, or lactating women
• Patients participating in another clinical study within the past 3 months before initiation of the present study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
The differences from the baseline in total sign and symptom scores on Days 3, 7
and 14 were compared between the two groups.
The differences from the baseline in anterior chamber cell score on Days 3 and 7
were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
14 were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 1 or less on Days
3, 7 and 14 were compared between the two groups.