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NCT00348335 Clinical Trial

Efficacy of Topical Cyclosporin for Ocular Rosacea

Rosacea Clinical Trial

Official title:
Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00348335
Other study ID # 32,133
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2006
Last updated July 28, 2011
Start date June 2006
Est. completion date September 2007

Study information
Verified date July 2011
Source Ophthalmic Consultants of Long Island
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine 0.05%

• Ocular lubricant

Locations
Country Name City State
United States 2500 Rte 347 Bldg 24 StonyBrook New York

Sponsors (2)
Lead Sponsor Collaborator
Ophthalmic Consultants of Long Island Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary hyperemia 6 months Yes
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