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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109056
First Posted: April 22, 2010
Last Update Posted: June 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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).

Condition Intervention Phase
Pterygium Drug: cyclosporine ophthalmic emulsion 0.05% Drug: Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.


Enrollment: 115
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
Drug: cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
Other Name: RESTASIS®
Placebo Comparator: Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)
Drug: Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01109056


Locations
United States, California
Glendale, California, United States
Australia, New South Wales
Randwick, New South Wales, Australia
Singapore
Singapore, Singapore
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01109056     History of Changes
Other Study ID Numbers: 192371-019
First Submitted: April 19, 2010
First Posted: April 22, 2010
Results First Submitted: May 22, 2012
Results First Posted: June 25, 2012
Last Update Posted: June 25, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye 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