Status:
COMPLETED
Efficacy of Topical Cyclosporin for Ocular Rosacea
Lead Sponsor:
Ophthalmic Consultants of Long Island
Collaborating Sponsors:
Allergan
Conditions:
Rosacea
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 controll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00348335
Start Date
June 1 2006
End Date
September 1 2007
Last Update
July 29 2011
Active Locations (1)
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1
2500 Rte 347 Bldg 24
Stony Brook, New York, United States, 11790