Efficacy of Topical Cyclosporin for Ocular Rosacea

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: Cyclosporine 0.05%; Drug: Ocular lubricant

• Registration Number: NCT00348335
• Lead Sponsor: Ophthalmic Consultants of Long Island

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 controlled on topical corticosteroids

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-28
• Last Update Posted: 2011-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Restasis	Cyclosporine 0.05%	-
2: Refresh Endura	Ocular lubricant	-

Primary Outcome Measures

Name	Time	Method
hyperemia	6 months

Trial Locations

Locations (1)

2500 Rte 347 Bldg 24; 🇺🇸 StonyBrook, New York, United States