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NCT00548301 Clinical Trial

Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00548301
Other study ID # ST-603-007
Secondary ID
Status Completed
Phase Phase 3
First received October 22, 2007
Last updated June 29, 2011

Study information
Verified date June 2011
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 phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

- Intraocular or refractive surgery in the study eye within 3 months prior to study start

- Unwilling to discontinue use of contact lenses during the run-in and duration of the study

- Pregnancy or lactation

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• cyclosporine

Locations
Country Name City State
United States Eye Center Northeast Bangor Maine

Sponsors (1)
Lead Sponsor Collaborator
Sirion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

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