A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
NCT ID: NCT05456425
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
660 participants
INTERVENTIONAL
2022-06-30
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle
Emulsion eye drop without drug
Vehicle
Formulation without drug
CBT-001 Low Dose
CBT-001 eye drop
CBT-001
CBT-001 eye drop
CBT-001 High Dose
CBT-001 eye drop
CBT-001
CBT-001 eye drop
Interventions
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CBT-001
CBT-001 eye drop
Vehicle
Formulation without drug
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Cloudbreak Therapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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Trinity Research Group
Dothan, Alabama, United States
Horizon Eye Specialists & LASIK Center
Sun City, Arizona, United States
West Coast Eye Institute
Bakersfield, California, United States
Global Research Mangement
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
Eye Research Foundation
Newport Beach, California, United States
Shultz Chang Vision
Northridge, California, United States
North Bay Eye Associates INC
Petaluma, California, United States
Santa Barbara Eye Care
Santa Barbara, California, United States
Advanced Research; LLC
Deerfield Beach, Florida, United States
Bruce A. Segal, MD
Delray Beach, Florida, United States
International Research Center
Tampa, Florida, United States
The Eye Care Institute
Louisville, Kentucky, United States
Center for Sight
Henderson, Nevada, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Baylor College of Medicine
Houston, Texas, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
R and R Eye Research
San Antonio, Texas, United States
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, United States
The Centre for Eye Research Australia
East Melbourne, Melbourne, Australia
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Bendigo Eye Clinic
Bendigo, Victoria, Australia
Sunshine Eye Surgeons
St Albans, Victoria, Australia
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, 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
Icare Eye Hospital
Noida, Uttar Pradesh, India
Auckland Eye
Auckland, , New Zealand
Eye Institute
Auckland, , New Zealand
Southern Eye Specialists
Christchurch, , New Zealand
Countries
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Other Identifiers
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CBT-CS301
Identifier Type: -
Identifier Source: org_study_id
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