Efficacy of Topical Cyclosporin for Ocular Rosacea - Tabular View

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

March 7, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

hyperemia

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00348335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy of Topical Cyclosporin for Ocular Rosacea

Official Title ^ICMJE

Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Brief Summary

The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Detailed Description

The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Rosacea

Intervention ^ICMJE

Drug: Cyclosporin 0.05% Ophthalmic Solution

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

Recruiting

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pt at least 18 yrs but younger than 65 Diagnosis of acne rosacea active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangectasia and hyperemia of at least 2+ Schirmers test of greater than 5mm in at least 1 eye If patient currently using lid hygiene must maintain regimen during study Stop oral antibiotics at least 4 weeks prior

Exclusion Criteria:

Use of topical cyclosporin within last 90 days Visual acuity of 20/100 or better in both eyes Pregnant or lactating females Active ocular infection Scarring of central cornea Eyelid defects,abnormal lid positioning or lagophthalmos Flax seed or Fish oil supplements within last 30 days

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: John R Wittpenn	631-941-1400	jwittpenn@ocli.net
Contact: Stacey Kruck	631-941-1400	skruck@ocli.net

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00348335

Responsible Party

Study ID Numbers ^ICMJE

32,133

Study Sponsor ^ICMJE

Ophthalmic Consultants of Long Island

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

Principal Investigator:

John R Wittpenn, MD

Ophthalmic Consultants of Long Island

Information Provided By

Ophthalmic Consultants of Long Island

Verification Date

March 2007

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