This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Efficacy of Topical Cyclosporin for Ocular Rosacea

This study has been completed.
Information provided by:
Ophthalmic Consultants of Long Island Identifier:
First received: June 30, 2006
Last updated: July 28, 2011
Last verified: July 2011
The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Condition Intervention Phase
Rosacea Drug: Cyclosporine 0.05% Drug: Ocular lubricant Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Resource links provided by NLM:

Further study details as provided by Ophthalmic Consultants of Long Island:

Primary Outcome Measures:
  • hyperemia [ Time Frame: 6 months ]

Enrollment: 35
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Restasis Drug: Cyclosporine 0.05%
Active Comparator: 2: Refresh Endura Drug: Ocular lubricant

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00348335

United States, New York
2500 Rte 347 Bldg 24
StonyBrook, New York, United States, 11790
Sponsors and Collaborators
Ophthalmic Consultants of Long Island
Principal Investigator: John R Wittpenn, MD Ophthalmic Consultants of Long Island
  More Information

Responsible Party: Dr. Eric Donnenfeld, OCLI Identifier: NCT00348335     History of Changes
Other Study ID Numbers: 32,133
Study First Received: June 30, 2006
Last Updated: July 28, 2011

Additional relevant MeSH terms:
Skin Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on August 23, 2017