Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)

This study has been completed.

Sponsor:

Information provided by:

Sirion Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT00502073

First received: July 13, 2007

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

June 29, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00502073 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)

Official Title ^ICMJE

Not Provided

Brief Summary

The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Dry Eye Syndromes

Intervention ^ICMJE

Drug: cyclosporine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00502073

Other Study ID Numbers ^ICMJE

ST-603-005

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sirion Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Roger Vogel, MD

Sirion Therapeutics

Information Provided By

Sirion Therapeutics, Inc.

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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