Efficacy of Topical Cyclosporin for Ocular Rosacea

This study has been completed.

First Received on June 30, 2006. Last Updated on July 28, 2011 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: Cyclosporine 0.05% Drug: Ocular lubricant	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	35
Study Start Date:	June 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1: Restasis	Drug: Cyclosporine 0.05%
Active Comparator: 2: Refresh Endura	Drug: Ocular lubricant

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:

Patient at least 18 years old, but younger than 65
Diagnosis of acne rosacea
Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia 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

Locations

United States, New York
2500 Rte 347 Bldg 24
StonyBrook, New York, United States, 11790

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

Responsible Party:	Dr. Eric Donnenfeld, OCLI
ClinicalTrials.gov Identifier:	NCT00348335 History of Changes
Other Study ID Numbers:	32,133
Study First Received:	June 30, 2006
Last Updated:	July 28, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012