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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Centre for Eye Research Australia, East Melbourne, Melbourne, Australia

About this study

Clinical Hypotheses:

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.
CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pterygium with conjunctival hyperemia

Exclusion criteria

Pterygium removal within the last 6 months

Treatment and study plan

CBT-001

Drug

CBT-001 eye drop

Vehicle

Drug

Formulation without drug

Primary outcomes

conjunctival hyperemia

Time frame: 3 month

Mean difference of conjunctival hyperemia grade change from baseline.
pterygium length

Time frame: 12 month

Mean difference of pterygium lesion length change from baseline.

Sponsors and collaborators

Lead sponsor

Cloudbreak Therapeutics, LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Jul 13, 2022
Registry last updated: Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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