Efficacy of Topical Cyclosporin for Ocular Rosacea

Ophthalmic Consultants of Long Island (OCLI) Vision

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Drug: Cyclosporine 0.05%; Drug: Ocular lubricant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00348335

32,133

Details and patient eligibility

About

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

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

1: Restasis

Active Comparator group

Treatment:

Drug: Cyclosporine 0.05%

2: Refresh Endura

Active Comparator group

Treatment:

Drug: Ocular lubricant