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

Recruiting
12 years of age
Both
Phase 3

Overview

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.

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.

Eligibility

Inclusion Criteria:

Pterygium with conjunctival hyperemia

Exclusion Criteria:

Pterygium removal within the last 6 months

Study details

Pterygium

NCT05456425

Cloudbreak Therapeutics, LLC

18 April 2024

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