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OpenTrials
Completed

NCT Number: NCT00348335

Efficacy of Topical Cyclosporin for Ocular Rosacea

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

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

2500 Rte 347 Bldg 24

Stony Brook, New York, 11790, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine 0.05%

Drug

Ocular lubricant

Drug

Primary outcomes

  1. hyperemia

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ophthalmic Consultants of Long Island

Other

Collaborators

  • Allergan

Registry information

Official study title

Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
Jul 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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