A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Clinical Hypotheses: 1. CBT-001 dosed twice daily is more effective than vehicle in: * Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline. * Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline. 2. CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Inclusion Criteria: Pterygium with conjunctival hyperemia Exclusion Criteria: Pterygium removal within the last 6 months