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

Phase 3

Recruiting

• Conditions: Pterygium
• Interventions: Drug: Vehicle; Drug: CBT-001

• Registration Number: NCT05456425
• Lead Sponsor: Cloudbreak Therapeutics, LLC

Brief 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.

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Pterygium with conjunctival hyperemia

Exclusion Criteria

Pterygium removal within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Emulsion eye drop without drug
CBT-001 High Dose	CBT-001	CBT-001 eye drop
CBT-001 Low Dose	CBT-001	CBT-001 eye drop

Primary Outcome Measures

Name	Time	Method
pterygium length	12 month	Mean difference of pterygium lesion length change from baseline.
conjunctival hyperemia	3 month	Mean difference of conjunctival hyperemia grade change from baseline.

Trial Locations

Locations (44)

Cornea and Cataract Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Walman Eye Center; 🇺🇸 Sun City, Arizona, United States

Bakersfield Eye Institute; 🇺🇸 Bakersfield, California, United States

West Coast Eye Institute; 🇺🇸 Bakersfield, California, United States

Global Research Mangement; 🇺🇸 Glendale, California, United States

Inland Eye Specialists; 🇺🇸 Hemet, California, United States

Shultz Chang Vision; 🇺🇸 Northridge, California, United States

Santa Barbara Eye Care; 🇺🇸 Santa Barbara, California, United States

Bruce A. Segal, MD; 🇺🇸 Delray Beach, Florida, United States

International Research Center; 🇺🇸 Tampa, Florida, United States

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