Study of Difluprednate in the Treatment of Uveitis

NCT ID: NCT00501579

Last Updated: 2008-08-29

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

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Difluprednate

Intervention Type DRUG

Prednisolone Acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of endogenous anterior uveitis in at least 1 eye

Exclusion Criteria

* Presence of intermediate uveitis, posterior uveitis or panuveitis
* Corneal abrasion
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
* Allergy to similar drugs, such as other corticosteroids
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Sirion Therapeutics

Principal Investigators

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Roger Vogel, MD

Role: STUDY_CHAIR

Sirion Therapeutics

Locations

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John-Kenyon American Eye Institute

New Albany, Indiana, United States

Site Status

Countries

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United States

References

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Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.

Reference Type DERIVED
PMID: 20809807 (View on PubMed)

Other Identifiers

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ST-601A-001

Identifier Type: -

Identifier Source: org_study_id