Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

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

Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).

The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe 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 in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Study Type

Interventional

Enrollment

20

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 with a diagnosis of endogenous anterior uveitis or panuveitis
  • Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
  • Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
  • Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
  • 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 initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
  • Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
  • Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
  • Patients with glaucoma or ocular hypertension
  • Patients with corneal erosion or corneal ulcer
  • Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
  • Patients with allergy to similar drugs of difluprednate
  • Patients requiring use of contact lens during the study period
  • Women who were or might be pregnant, or lactating women
  • Patients participating in another clinical study within 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The anterior chamber cell score was compared between baseline and Day 14.

Secondary Outcome Measures

Outcome Measure
The anterior chamber cell score was compared between baseline and Days 3 and 7.
The total symptom score (sum of eye pain, photophobia, blurred
vision, foreign body sensation and lacrimation scores) and total
sign score (sum of anterior chamber cell, anterior chamber flare,
ciliary hyperemia, keratic precipitate and synechia of iris and
posterior scores) were compared between baseline and Days 3, 7
and 14.

Collaborators and Investigators

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

Sponsor

Sirion Therapeutics, Inc.

Investigators

  • Principal Investigator: Shigeaki Ono, 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

June 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

  • SJE2079/3-02-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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