Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

November 29, 2006 updated by: Sirion Therapeutics, Inc.

Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

24

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirion Therapeutics, Inc.

Investigators

  • Study Chair: Kanjiro Masudo, Director, Kanto Rosai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion

April 1, 2001

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJE2079/2-02-PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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