Official Title: “Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea”

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

Study Type: Interventional

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

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

Intervention(s) in this Clinical Trial

• Drug: Cyclosporin 0.05% Ophthalmic Solution

Primary Measures

• hyperemia

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Ophthalmic Consultants of Long Island

Overall Clinical Trial Officials and Contacts

John R Wittpenn, MD Principal Investigator Ophthalmic Consultants of Long Island  

Overall Contact: John R Wittpenn 631-941-1400 jwittpenn@ocli.net

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348335

Study ID Number: 32,133

ClinicalTrials.gov Identifier: NCT00348335

Health Authority: United States: Institutional Review Board