Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis - Full Text View

Sponsored by:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00405496

Purpose

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

Condition	Intervention	Phase
Anterior Uveitis	Drug: Difluprednate Ophthalmic Emulsion	Phase II

Drug Information available for: Difluprednate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

Further study details as provided by Sirion Therapeutics, Inc.:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	24
Study Start Date:	March 2000
Estimated Study Completion Date:	April 2001

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405496

Sponsors and Collaborators

Sirion Therapeutics, Inc.

Investigators

Study Chair:

Kanjiro Masudo

Director, Kanto Rosai Hospital

More Information

Study ID Numbers:	SJE2079/2-02-PC
Study First Received:	November 29, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00405496
Health Authority:	Japan: Institutional Review Board

Study placed in the following topic categories:

Uveitis, Anterior
Panuveitis
Iridocyclitis

Uveitis
Eye Diseases
Iritis

Additional relevant MeSH terms:

Uveal Diseases

ClinicalTrials.gov processed this record on January 14, 2009