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

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

February 29, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Dry Eye Syndromes

Intervention ^ICMJE

Drug: cyclosporine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00502073

Responsible Party

Study ID Numbers ^ICMJE

ST-603-005

Study Sponsor ^ICMJE

Sirion Therapeutics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Roger Vogel, MD

Sirion Therapeutics

Information Provided By

Sirion Therapeutics, Inc.

Verification Date

February 2008

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