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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01109056
• Date of registration: 19/04/2010
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
• Date of first enrolment: June 2010
• Target sample size: 115
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01109056
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Singapore, United States

Contacts

• Name: Medical Director
• Affiliation: Allergan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pterygium

Intervention(s)

Drug: Vehicle

Drug: cyclosporine ophthalmic emulsion 0.05%

Primary Outcome(s)

Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 [Time Frame: Baseline, Week 16]

Number of Pterygium Hyperemia Responders at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 [Time Frame: Baseline, Week 16]

Secondary ID(s)

192371-019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01109056