- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109056
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
May 22, 2012 updated by: Allergan
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Randwick, New South Wales, Australia
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Singapore, Singapore
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California
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Glendale, California, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
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One drop in the study eye (or eyes) administered four times daily (QID)
Other Names:
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Placebo Comparator: Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)
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One drop in the study eye (or eyes) administered four times daily (QID)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Pterygium Hyperemia Responders at Week 16
Time Frame: Week 16
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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.
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Week 16
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Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Time Frame: Baseline, Week 16
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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.
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Baseline, Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
Time Frame: Baseline, Week 16
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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.
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Baseline, Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 21, 2010
First Posted (Estimate)
April 22, 2010
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
May 22, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Conjunctival Diseases
- Pterygium
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 192371-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on cyclosporine ophthalmic emulsion 0.05%
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AllerganCompletedDry Eye SyndromesUnited States
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Taejoon Pharmaceutical Co., Ltd.CompletedDry Eye | Dry Eye SyndromesKorea, Republic of
-
AllerganCompleted
-
Aurinia Pharmaceuticals Inc.Completed
-
AllerganCompleted
-
AllerganCompletedKeratoconjunctivitis SiccaUnited States
-
AllerganCompletedDry Eye SyndromesUnited States
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Baylor College of MedicineAllerganTerminatedDry EyeUnited States
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AllerganCompletedArthritis, Rheumatoid | Lupus Erythematosus, Systemic | Scleroderma, Systemic | Keratoconjunctivitis Sicca | Sjogren's SyndromeUnited States