Rosacea
Conditions
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
Interventions
DRUGCyclosporine 0.05%
DRUGOcular lubricant
Sponsors
Allergan
Ophthalmic Consultants of Long Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hyperemia | 6 months |
Countries
United States
Outcome results
None listed