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Efficacy of Topical Cyclosporin for Ocular Rosacea

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ClinicalTrials.gov Identifier: NCT00348335
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 29, 2011
Sponsor:
Collaborator:
Allergan
Information provided by:
Ophthalmic Consultants of Long Island

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

Condition or disease Intervention/treatment Phase
Rosacea Drug: Cyclosporine 0.05% Drug: Ocular lubricant Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Rosacea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1: Restasis Drug: Cyclosporine 0.05%
Active Comparator: 2: Refresh Endura Drug: Ocular lubricant



Primary Outcome Measures :
  1. hyperemia [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Eric Donnenfeld, OCLI
ClinicalTrials.gov Identifier: NCT00348335     History of Changes
Other Study ID Numbers: 32,133
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Cyclosporins
Cyclosporine
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