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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014