Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Anterior Uveitis Panuveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Difluprednate Ophthalmic Emulsion

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Shigeaki Ohno, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University

Other Identifiers

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SJE2079/3-01-PC

Identifier Type: -

Identifier Source: org_study_id