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

Pterygium Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109056
• Other study ID #: 192371-019
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2010
• Last updated: May 22, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Drug:
• cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
• Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 16	No
Primary	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.	Baseline, Week 16	No
Secondary	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.	Baseline, Week 16	No