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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 660
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)
Trinity Research Group
🇺🇸Dothan, Alabama, United States
Horizon Eye Specialists & LASIK Center
🇺🇸Sun City, Arizona, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
North Bay Eye Associates INC
🇺🇸Petaluma, California, United States
Advanced Research; LLC
🇺🇸Deerfield Beach, Florida, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
R and R Eye Research
🇺🇸San Antonio, Texas, United States
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Bendigo Eye Clinic
🇦🇺Bendigo, Victoria, Australia
West Coast Eye Institute
🇺🇸Bakersfield, California, United States
Scroll for more (34 remaining)Trinity Research Group🇺🇸Dothan, Alabama, United States