Clinical Hypotheses:~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.~CBT-001 emulsion maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.
The objective is to evaluate the safety and efficacy of 0.1% and 0.2% CBT-001 emulsion dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.