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

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cyclosporine ophthalmic emulsion 0.05%
Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

cyclosporine ophthalmic emulsion 0.05%

Vehicle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Pterygium Hyperemia Responders at 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
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
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.

Full Information

First Posted
April 19, 2010
Last Updated
May 22, 2012
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01109056
Brief Title
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cyclosporine ophthalmic emulsion 0.05%
Arm Type
Experimental
Arm Description
One drop in the study eye (or eyes) administered four times daily (QID)
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop in the study eye (or eyes) administered four times daily (QID)
Intervention Type
Drug
Intervention Name(s)
cyclosporine ophthalmic emulsion 0.05%
Other Intervention Name(s)
RESTASIS®
Intervention Description
One drop in the study eye (or eyes) administered four times daily (QID)
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
One drop in the study eye (or eyes) administered four times daily (QID)
Primary Outcome Measure Information:
Title
Number of Pterygium Hyperemia Responders at Week 16
Description
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.
Time Frame
Week 16
Title
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Description
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.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
Description
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.
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
Country
United States
City
Randwick
State/Province
New South Wales
Country
Australia
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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

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