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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00501579
Other study ID # ST-601A-001
Secondary ID
Status Completed
Phase Phase 3
First received July 13, 2007
Last updated August 27, 2008

Study information

Verified date August 2008
Source Sirion Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 2 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Drug:
Difluprednate

Prednisolone Acetate


Locations

Country Name City State
United States John-Kenyon American Eye Institute New Albany Indiana

Sponsors (1)

Lead Sponsor Collaborator
Sirion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

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