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

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.