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Efficacy of Topical Cyclosporin for Ocular Rosacea

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier:
NCT00348335
First received: June 30, 2006
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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

Primary Outcome Measures:
  • hyperemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348335

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

No publications provided

Responsible Party: Dr. Eric Donnenfeld, OCLI
ClinicalTrials.gov Identifier: NCT00348335     History of Changes
Other Study ID Numbers: 32,133
Study First Received: June 30, 2006
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013