Efficacy of Topical Cyclosporin for Ocular Rosacea

This study is currently recruiting participants.

Verified by Ophthalmic Consultants of Long Island, March 2007

First Received: June 30, 2006 Last Updated: March 7, 2007 History of Changes

Sponsor:	Ophthalmic Consultants of Long Island
Collaborator:	Allergan
Information provided by:	Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier:	NCT00348335

Purpose

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

Condition	Intervention	Phase
Rosacea	Drug: Cyclosporin 0.05% Ophthalmic Solution	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Ophthalmic Consultants of Long Island:

Primary Outcome Measures:

hyperemia

Estimated Enrollment:	50
Study Start Date:	June 2006
Estimated Study Completion Date:	September 2007

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348335

Contacts

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

Locations

United States, New York
2500 Rte 347 Bldg 24	Recruiting
StonyBrook, New York, United States, 11790
Principal Investigator: John R Wittpenn

Sponsors and Collaborators

Ophthalmic Consultants of Long Island

Allergan

Investigators

Principal Investigator:

John R Wittpenn, MD

Ophthalmic Consultants of Long Island

More Information

No publications provided

Study ID Numbers:	32,133
Study First Received:	June 30, 2006
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00348335 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Rosacea
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 05, 2009