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
Status: Active_not_recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Pterygium with conjunctival hyperemia
Locations
United States
Alabama
Trinity Research Group
Dothan
Arizona
Horizon Eye Specialists & LASIK Center
Sun City
California
West Coast Eye Institute
Bakersfield
Global Research Mangement
Glendale
Inland Eye Specialists
Hemet
Eye Research Foundation
Newport Beach
Shultz Chang Vision
Northridge
North Bay Eye Associates INC
Petaluma
Santa Barbara Eye Care
Santa Barbara
Florida
Advanced Research; LLC
Deerfield Beach
Bruce A. Segal, MD
Delray Beach
International Research Center
Tampa
Kentucky
The Eye Care Institute
Louisville
Nevada
Center for Sight
Henderson
South Dakota
Vance Thompson Vision
Sioux Falls
Texas
Baylor College of Medicine
Houston
DCT-Shah Research, LLC dba Discovery Clinical Trials
Mcallen
Clinical Trials of Texas
San Antonio
R and R Eye Research
San Antonio
Virginia
Emerson Clinical Research Institute, LLC
Falls Church
Other Locations
Australia
Eyeclinic Albury Wodonga
Albury
Bendigo Eye Clinic
Bendigo
The Centre for Eye Research Australia
East Melbourne
Sunshine Eye Surgeons
St Albans
Sydney Eye Hospital
Sydney
China
Beijing Tongren Hospital; CMU
Beijing
West China Hospital of Sichuan University
Chengdu
Hainan Provincial Eye Hospital
Haikou
1st Affiliated Hospital of University of South China
Hengyang
The Second People's Hospital of Yunnan Province
Kunming
The First Affiliated Hospital of NC University
Nanchang
Eye Hospital of Shandong First Medical University
Qingdao
Eye Hospital of Wenzhou Medical University
Wenzhou
Union Hospital Tongji Medical College
Wuhan
Xiamen Eye Center of Xiamen University
Xiamen
India
Netralaya Super Specialty Eye Hospital
Ahmedabad
Narayana Nethralaya
Bangalore
L V Prasad Eye Institute
Bhubaneswar
SP Medical College and AG of Hospitals
Bikaner
Advanced Eye Centre PGIMER
Chandigarh
Icare Eye Hospital
Noida
New Zealand
Auckland Eye
Auckland
Eye Institute
Auckland
Southern Eye Specialists
Christchurch
Time Frame
Start Date: 2022-06-30
Completion Date: 2027-12-31
Participants
Target number of participants: 660
Treatments
Placebo_comparator: Vehicle
Emulsion eye drop without drug
Experimental: CBT-001 Low Dose
CBT-001 eye drop
Experimental: CBT-001 High Dose
CBT-001 eye drop
Related Therapeutic Areas
Sponsors
Leads: Cloudbreak Therapeutics, LLC