Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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

Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

140

Phase

  • Phase 3

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Secondary Outcome Measures

Outcome Measure
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 differences from the baseline in total sign and symptom scores on Days 3, 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.

Collaborators and Investigators

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

Sponsor

Sirion Therapeutics, Inc.

Investigators

  • Principal Investigator: Shigeaki Ohno, PhD, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University

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

August 1, 2002

Study Completion

November 1, 2003

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 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

  • SJE2079/3-01-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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