Efficacy of Topical Cyclosporin for Ocular Rosacea

Verified by: Ophthalmic Consultants of Long Island, July 2011
First Received: June 30, 2006 | Last Updated: July 28, 2011 | Phase: Phase 4 | Start Date: June 2006
Overall Status: Completed | Estimated Enrollment: 35
  • …
  • Tell a FriendPrint

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

Brief Summary

Official Title: “Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2007

Detailed Clinical Trial 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

Intervention(s) in this Clinical Trial

  • Drug: Cyclosporine 0.05%
  • Drug: Ocular lubricant

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1: Restasis
  • Active Comparator: 2: Refresh Endura

Outcome Measures for this Clinical Trial

Primary Measures

  • hyperemia
    • Time Frame: 6 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Ophthalmic Consultants of Long Island Other

Overall Clinical Trial Officials and Contacts

John R Wittpenn, MD Principal Investigator Ophthalmic Consultants of Long Island  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348335

Study ID Number: 32,133

ClinicalTrials.gov Identifier: NCT00348335

Health Authority: United States: Institutional Review Board

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00348335