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

NCT05456425 · tracked via the Priya Life Science India tracker

Sponsor

Cloudbreak Therapeutics, LLC

Phase

Phase 3

Started

2022-06-30

Last updated

2025-09-24

Condition(s) studied

Pterygium

Investigational drug(s) / intervention(s)

CBT-001Vehicle

CBT-001: CBT-001 eye drop

Vehicle: Formulation without drug

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Pterygium with conjunctival hyperemia Exclusion Criteria: Pterygium removal within the last 6 months

Primary outcome measure(s)

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

Trial sites (44)

Facility	City	Region
Trinity Research Group	Dothan	Alabama
Horizon Eye Specialists & LASIK Center	Sun City	Arizona
West Coast Eye Institute	Bakersfield	California
Global Research Mangement	Glendale	California
Inland Eye Specialists	Hemet	California
Eye Research Foundation	Newport Beach	California
Shultz Chang Vision	Northridge	California
North Bay Eye Associates INC	Petaluma	California
Santa Barbara Eye Care	Santa Barbara	California
Advanced Research; LLC	Deerfield Beach	Florida
Bruce A. Segal, MD	Delray Beach	Florida
International Research Center	Tampa	Florida
The Eye Care Institute	Louisville	Kentucky
Center for Sight	Henderson	Nevada
Vance Thompson Vision	Sioux Falls	South Dakota
Baylor College of Medicine	Houston	Texas
DCT-Shah Research, LLC dba Discovery Clinical Trials	McAllen	Texas
Clinical Trials of Texas	San Antonio	Texas
R and R Eye Research	San Antonio	Texas
Emerson Clinical Research Institute, LLC	Falls Church	Virginia
The Centre for Eye Research Australia	East Melbourne	Melbourne
Eyeclinic Albury Wodonga	Albury	New South Wales
Sydney Eye Hospital	Sydney	New South Wales
Bendigo Eye Clinic	Bendigo	Victoria
Sunshine Eye Surgeons	St Albans	Victoria
Beijing Tongren Hospital; CMU	Beijing	China
West China Hospital of Sichuan University	Chengdu	China
Hainan Provincial Eye Hospital	Haikou	China
1st Affiliated Hospital of University of South China	Hengyang	China
The Second People's Hospital of Yunnan Province	Kunming	China
The First Affiliated Hospital of NC University	Nanchang	China
Eye Hospital of Shandong First Medical University	Qingdao	China
Eye Hospital of Wenzhou Medical University	Wenzhou	China
Union Hospital Tongji Medical College	Wuhan	China
Xiamen Eye Center of Xiamen University	Xiamen	China
Advanced Eye Centre PGIMER	Chandigarh	Chandigarh
Netralaya Super Specialty Eye Hospital	Ahmedabad	Gujarat
Narayana Nethralaya	Bangalore	Karnataka
L V Prasad Eye Institute	Bhubaneswar	Odisha
SP Medical College and AG of Hospitals	Bikaner	Rajasthan

+ 4 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05456425 on ClinicalTrials.gov ↗ ← All trials in India