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Completed

NCT Number: NCT01109056

Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a pterygium in at least one eye that has not been previously removed with surgery

Exclusion criteria

  • Uncontrolled systemic disease
  • Active eye disease
  • Current or anticipated use of topical eye medications other than artificial tears.
  • Anticipated wearing of contact lenses

Treatment and study plan

cyclosporine ophthalmic emulsion 0.05%

Drug

One drop in the study eye (or eyes) administered four times daily (QID)

Other names: RESTASIS®

Vehicle

Drug

One drop in the study eye (or eyes) administered four times daily (QID)

Primary outcomes

  1. Number of Pterygium Hyperemia Responders at Week 16

    Time frame: Week 16

    Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.

  2. Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16

    Time frame: Baseline, Week 16

    Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.

Secondary outcomes

  1. Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16

    Time frame: Baseline, Week 16

    Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2010
Registry last updated
Jun 25, 2012

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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