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NCT05456425 Clinical Trial

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

Pterygium Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05456425
Other study ID # CBT-CS301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 30, 2022
Est. completion date December 31, 2026

Study information
Verified date March 2024
Source Cloudbreak Therapeutics, LLC
Contact Abu Abraham, MD
Phone 949-234-7147
Email CBT-CS301Study@cloudbreakpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: Pterygium with conjunctival hyperemia Exclusion Criteria: Pterygium removal within the last 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CBT-001
CBT-001 eye drop
• Vehicle
Formulation without drug

Locations
Country Name City State
Australia Eyeclinic Albury Wodonga Albury New South Wales
Australia The Centre for Eye Research Australia East Melbourne Melbourne
Australia Sunshine Eye Surgeons St Albans Victoria
China 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
India M and J Western Ahmedabad Gujarat
India Netralaya Super Specialty Eye Hospital Ahmedabad Gujarat
India Narayana Nethralaya Bangalore Karnataka
India L V Prasad Eye Institute Bhubaneswar Odisha
India SP Medical College and AG of Hospitals Bikaner Rajasthan
India Advanced Eye Centre PGIMER Chandigarh
India Chopda Medicare Nashik Maharashtra
India Icare Eye Hospital Noida Uttar Pradesh
New Zealand Auckland Eye Auckland
New Zealand Eye Institute Auckland
New Zealand Southern Eye Specialists Christchurch
United States Bakersfield Eye Institute Bakersfield California
United States West Coast Eye Institute Bakersfield California
United States Bruce A. Segal, MD Delray Beach Florida
United States Emerson Clinical Research Institute, LLC Falls Church Virginia
United States Global Research Mangement Glendale California
United States Inland Eye Specialists Hemet California
United States Center for Sight Henderson Nevada
United States Baylor College of Medicine Houston Texas
United States Wellish Vision Institute Las Vegas Nevada
United States The Eye Care Institute Louisville Kentucky
United States DCT-Shah Research, LLC dba Discovery Clinical Trials McAllen Texas
United States Wagner Macula & Retina Center Norfolk Virginia
United States Shultz Chang Vision Northridge California
United States Cornea and Cataract Consultants of Arizona Phoenix Arizona
United States R and R Eye Research, LLC San Antonio Texas
United States Santa Barbara Eye Care Santa Barbara California
United States Vance Thompson Vision Sioux Falls South Dakota
United States Mercy Clinic Eye Specialists Springfield Missouri
United States Walman Eye Center Sun City Arizona
United States International Research Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Cloudbreak Therapeutics, LLC

Countries where clinical trial is conducted

United States,  Australia,  China,  India,  New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary conjunctival hyperemia Mean difference of conjunctival hyperemia grade change from baseline. 3 month
Primary pterygium length Mean difference of pterygium lesion length change from baseline. 12 month
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