Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Phase 2

Completed

• Conditions: Anterior Uveitis

• Registration Number: NCT00405496
• Lead Sponsor: Sirion Therapeutics, Inc.

Brief Summary

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Detailed Description

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.

The secondary objective was to establish the evaluation system for a dose-finding study.

Study Timeline

• Study Start: 2000-03
• Study Completion: 2001-04
• 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: 2006-11-30
• Last Update Posted: 2006-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients with endogenous anterior uveitis (including panuveitis)
• Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope
• Patients aged ≥20 years and <75 years who could clearly express their subjective symptoms (Patients aged 20 years at giving informed consent were included in the study.)
• Patients giving written informed consent prior to initiation of the study

Exclusion Criteria

• Patients who did not meet all of the above inclusion criteria
• Patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug
• Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
• Patients with corneal erosion or corneal ulcer
• Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
• Patients with diabetes mellitus
• Patients with allergy to corticosteroids
• Patients requiring use of contact lens during the study period
• Women who were or might be pregnant
• Patients participating in other clinical studies within 6 months before initiation of the present study
• Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
• Patients with fibrins to such an extent that might affect measurement of flare

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The anterior chamber cell score was compared between baseline and after completion of the
study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
reduction of anterior chamber cell.

Secondary Outcome Measures

Name	Time	Method
The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
(baseline/after completion of the study treatment ratio), as measured with a laser flare cell
meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
signs and symptoms after completion of the study treatment (142 days) from baseline.