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Efficacy of Topical Cyclosporin for Ocular Rosacea

Phase 4
Completed
Conditions
Rosacea
Interventions
Drug: Ocular lubricant
Registration Number
NCT00348335
Lead Sponsor
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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1: RestasisCyclosporine 0.05%-
2: Refresh EnduraOcular lubricant-
Primary Outcome Measures
NameTimeMethod
hyperemia6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

2500 Rte 347 Bldg 24

🇺🇸

StonyBrook, New York, United States

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