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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01109056
First received: April 19, 2010
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Pterygium Hyperemia Responders at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01109056     History of Changes
Other Study ID Numbers: 192371-019
Study First Received: April 19, 2010
Results First Received: May 22, 2012
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013