NCT05456425

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Cloudbreak Therapeutics, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pterygium

Interventions

Type	Name	Description
DRUG	CBT-001	CBT-001 eye drop
DRUG	Vehicle	Formulation without drug

Timeline

• Start date: 2022-06-30
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-07-13
• Last updated: 2025-09-24

Locations

44 sites across 5 countries: United States, Australia, China, India, New Zealand

Regulatory

• FDA-regulated drug study