Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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ClinicalTrials.gov Identifier: NCT00406887

Recruitment Status : Completed

First Posted : December 4, 2006

Last Update Posted : December 4, 2006

Sponsor:

Information provided by:

Sirion Therapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anterior Uveitis Panuveitis	Drug: Difluprednate Ophthalmic Emulsion	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
Study Start Date :	August 2002
Study Completion Date :	November 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Difluprednate

Genetic and Rare Diseases Information Center resources: Panuveitis Anterior Uveitis Uveal Diseases

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406887

Sponsors and Collaborators

Sirion Therapeutics, Inc.

Investigators

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

More Information

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ClinicalTrials.gov Identifier:	NCT00406887
Other Study ID Numbers:	SJE2079/3-01-PC
First Posted:	December 4, 2006 Key Record Dates
Last Update Posted:	December 4, 2006
Last Verified:	November 2006

Additional relevant MeSH terms:

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Uveitis Uveitis, Anterior Iridocyclitis Panuveitis Uveal Diseases Eye Diseases	Iris Diseases Difluprednate Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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