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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


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

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