Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

NCT ID: NCT00405496

Last Updated: 2006-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2001-04-30

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.

Conditions

Anterior Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Difluprednate Ophthalmic Emulsion

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Kanjiro Masudo

Role: STUDY_CHAIR

Director, Kanto Rosai Hospital

Other Identifiers

SJE2079/2-02-PC

Identifier Type: -

Identifier Source: org_study_id