A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
- Registration Number
- NCT05456425
- Lead Sponsor
- Cloudbreak Therapeutics, LLC
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Pterygium with conjunctival hyperemia
Pterygium removal within the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Emulsion eye drop without drug CBT-001 High Dose CBT-001 CBT-001 eye drop CBT-001 Low Dose CBT-001 CBT-001 eye drop
- Primary Outcome Measures
Name Time Method pterygium length 12 month Mean difference of pterygium lesion length change from baseline.
conjunctival hyperemia 3 month Mean difference of conjunctival hyperemia grade change from baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
The Eye Care Institute
๐บ๐ธLouisville, Kentucky, United States
The Centre for Eye Research Australia
๐ฆ๐บEast Melbourne, Melbourne, Australia
Eyeclinic Albury Wodonga
๐ฆ๐บAlbury, New South Wales, Australia
Global Research Mangement
๐บ๐ธGlendale, California, United States
Advanced Eye Centre PGIMER
๐ฎ๐ณChandigarh, India
Eye Institute
๐ณ๐ฟAuckland, New Zealand
Chopda Medicare
๐ฎ๐ณNashik, Maharashtra, India
Southern Eye Specialists
๐ณ๐ฟChristchurch, New Zealand
West Coast Eye Institute
๐บ๐ธBakersfield, California, United States
Inland Eye Specialists
๐บ๐ธHemet, California, United States
Santa Barbara Eye Care
๐บ๐ธSanta Barbara, California, United States
Mercy Clinic Eye Specialists
๐บ๐ธSpringfield, Missouri, United States
Center for Sight
๐บ๐ธHenderson, Nevada, United States
Baylor College of Medicine
๐บ๐ธHouston, Texas, United States
Bakersfield Eye Institute
๐บ๐ธBakersfield, California, United States
Shultz Chang Vision
๐บ๐ธNorthridge, California, United States
Wagner Macula & Retina Center
๐บ๐ธNorfolk, Virginia, United States
Auckland Eye
๐ณ๐ฟAuckland, New Zealand
West China Hospital of Sichuan University
๐จ๐ณChengdu, China
Beijing Tongren Hospital; CMU
๐จ๐ณBeijing, China
Hainan Provincial Eye Hospital
๐จ๐ณHaikou, China
1st Affiliated Hospital of University of South China
๐จ๐ณHengyang, China
The Second People's Hospital of Yunnan Province
๐จ๐ณKunming, China
The First Affiliated Hospital of NC University
๐จ๐ณNanchang, China
Eye Hospital of Shandong First Medical University
๐จ๐ณQingdao, China
Eye Hospital of Wenzhou Medical University
๐จ๐ณWenzhou, China
Union Hospital Tongji Medical College
๐จ๐ณWuhan, China
Xiamen Eye Center of Xiamen University
๐จ๐ณXiamen, China
SP Medical College and AG of Hospitals
๐ฎ๐ณBฤซkaner, Rajasthan, India
Sunshine Eye Surgeons
๐ฆ๐บSt Albans, Victoria, Australia
Walman Eye Center
๐บ๐ธSun City, Arizona, United States
Netralaya Super Specialty Eye Hospital
๐ฎ๐ณAhmedabad, Gujarat, India
Narayana Nethralaya
๐ฎ๐ณBangalore, Karnataka, India
Vance Thompson Vision
๐บ๐ธSioux Falls, South Dakota, United States
M and J Western
๐ฎ๐ณAhmedabad, Gujarat, India
L V Prasad Eye Institute
๐ฎ๐ณBhubaneswar, Odisha, India
Icare Eye Hospital
๐ฎ๐ณNoida, Uttar Pradesh, India
Cornea and Cataract Consultants of Arizona
๐บ๐ธPhoenix, Arizona, United States
International Research Center
๐บ๐ธTampa, Florida, United States
Wellish Vision Institute
๐บ๐ธLas Vegas, Nevada, United States
R and R Eye Research, LLC
๐บ๐ธSan Antonio, Texas, United States
Bruce A. Segal, MD
๐บ๐ธDelray Beach, Florida, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
๐บ๐ธMcAllen, Texas, United States
Emerson Clinical Research Institute, LLC
๐บ๐ธFalls Church, Virginia, United States