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

Pterygium Clinical Trial

Official title:
Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 Versus Vehicle, Dosed Twice-Daily, in Patients With Pterygium

Clinical Trial Summary

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 Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05456425
Study type Interventional
Source Cloudbreak Therapeutics, LLC
Contact Abu Abraham, MD
Phone 949-234-7147
Email CBT-CS301Study@cloudbreakpharma.com
Status Recruiting
Phase Phase 3
Start date June 30, 2022
Completion date December 31, 2026
View Details
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