A phase III clinical trial on the safety and efficacy of CBT-001 in patients with pterygium

Cloudbreak Therapeutics, LLC is starting a new clinical trial of A Phase III Clinical Trial on the Safety and Efficacy of CBT-001 in Patients With Pterygium.

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.

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 on a 5-point scale. - Preventing pterygium progression, by (a) demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline as measured from the anterior edge of the limbus to the pterygium apex; and (b) demonstrating a statistically significant mean difference in improving subject-reported eye symptom score change from baseline. 2. CBT-001 emulsion maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

The clinical trial started in June 30, 2022 and will continue throughout June 30, 2025.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05456425 or https://clinicaltrials.gov/ct2/show/NCT05456425.