Efficacy of Topical Cyclosporin for Ocular Rosacea
Information source: Ophthalmic Consultants of Long Island
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Cyclosporin 0.05% Ophthalmic Solution (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ophthalmic Consultants of Long Island Official(s) and/or principal investigator(s):
John R Wittpenn, MD, Principal Investigator, Affiliation: Ophthalmic Consultants of Long Island
Overall contact:
John R Wittpenn, Phone: 631-941-1400, Email: jwittpenn@ocli.net
Summary
The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective
in the treatment of ocular rosacea
Clinical Details
Official title: Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: hyperemia
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pt at least 18 yrs but younger than 65 Diagnosis of acne rosacea active ocular rosacea
based on lid findings of meibomian gland dysfunction with lid telangectasia 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
Locations and Contacts
John R Wittpenn, Phone: 631-941-1400, Email: jwittpenn@ocli.net
2500 Rte 347 Bldg 24, StonyBrook, New York 11790, United States; Recruiting
John R Wittpenn, Principal Investigator
Additional Information
Starting date: June 2006
Ending date: September 2007
Last updated: March 7, 2007
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