A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
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
1 other identifier
interventional
660
5 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2022
Longer than P75 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
July 9, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 24, 2025
September 1, 2025
4.5 years
July 9, 2022
September 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
conjunctival hyperemia
Mean difference of conjunctival hyperemia grade change from baseline.
3 month
pterygium length
Mean difference of pterygium lesion length change from baseline.
12 month
Study Arms (3)
Vehicle
PLACEBO COMPARATOREmulsion eye drop without drug
CBT-001 Low Dose
EXPERIMENTALCBT-001 eye drop
CBT-001 High Dose
EXPERIMENTALCBT-001 eye drop
Interventions
Eligibility Criteria
You may qualify if:
- Pterygium with conjunctival hyperemia
You may not qualify if:
- Pterygium removal within the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Trinity Research Group
Dothan, Alabama, 36301, United States
Horizon Eye Specialists & LASIK Center
Sun City, Arizona, 83531, United States
West Coast Eye Institute
Bakersfield, California, 93311, United States
Global Research Mangement
Glendale, California, 91204, United States
Inland Eye Specialists
Hemet, California, 92545, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Shultz Chang Vision
Northridge, California, 91325, United States
North Bay Eye Associates INC
Petaluma, California, 94954, United States
Santa Barbara Eye Care
Santa Barbara, California, 93105, United States
Advanced Research; LLC
Deerfield Beach, Florida, 33064, United States
Bruce A. Segal, MD
Delray Beach, Florida, 33484, United States
International Research Center
Tampa, Florida, 33603, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Center for Sight
Henderson, Nevada, 89052, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78572, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
R and R Eye Research
San Antonio, Texas, 78229, United States
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, 22046, United States
The Centre for Eye Research Australia
East Melbourne, Melbourne, 3002, Australia
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640, Australia
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Bendigo Eye Clinic
Bendigo, Victoria, 3021, Australia
Sunshine Eye Surgeons
St Albans, Victoria, 3021, Australia
Beijing Tongren Hospital; CMU
Beijing, 100730, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Hainan Provincial Eye Hospital
Haikou, 570311, China
1st Affiliated Hospital of University of South China
Hengyang, 421001, China
The Second People's Hospital of Yunnan Province
Kunming, 650021, China
The First Affiliated Hospital of NC University
Nanchang, 330006, China
Eye Hospital of Shandong First Medical University
Qingdao, 250021, China
Eye Hospital of Wenzhou Medical University
Wenzhou, 325027, China
Union Hospital Tongji Medical College
Wuhan, 430022, China
Xiamen Eye Center of Xiamen University
Xiamen, 361004, China
Advanced Eye Centre PGIMER
Chandigarh, Chandigarh, 160012, India
Netralaya Super Specialty Eye Hospital
Ahmedabad, Gujarat, 380006, India
Narayana Nethralaya
Bangalore, Karnataka, 560010, India
L V Prasad Eye Institute
Bhubaneswar, Odisha, 751024, India
SP Medical College and AG of Hospitals
Bikaner, Rajasthan, 334001, India
Icare Eye Hospital
Noida, Uttar Pradesh, 201301, India
Auckland Eye
Auckland, 1050, New Zealand
Eye Institute
Auckland, 1050, New Zealand
Southern Eye Specialists
Christchurch, 8013, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2022
First Posted
July 13, 2022
Study Start
June 30, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share