Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 7, 2006

Last Updated Date

June 8, 2006

Start Date ^†

November 2005

Current Primary Outcome Measures ^†

Ocular exams and questionnaires at baseline and at 3 months will determine
the effect of cyclosporine on dry eye syndrome.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Increased contact lens wearing time due to a decrease in severity
of dry eye symptoms

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Official Title ^†

Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Brief Summary

Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome.

The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Condition ^†

Contact Lens Wearers With Dry Eye Syndrome

Intervention ^†

Drug: cyclosporine ophthalmic emulsion

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 ^†

Completed

Enrollment ^†

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

contact lens wearer
clinical diagnosis of dry eye syndrome

Exclusion Criteria:

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335114

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Alabama at Birmingham

Collaborators ^††

Investigators ^†

Principal Investigator:

Carol E Rosenstiel, OD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.