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NCT05456425 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
A Phase 3 study of Pterygium, sponsored by Cloudbreak Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT05456425: Active Phase 3 study of Pterygium, sponsored by Cloudbreak Therapeutics.
NCT05456425 is a Phase 3 study of Pterygium that is active but no longer recruiting, run by Cloudbreak Therapeutics. The registered enrollment target is 660 participants, above the 46-participant average among 3 other Pterygium trials with a reported enrollment target (1335% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05456425, a Phase 3 study of Pterygium, is active but no longer recruiting, sponsored by Cloudbreak Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Mean difference of conjunctival hyperemia grade change from baseline.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG CBT-001
Study Locations (20)
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
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
Florida
- Advanced Research; LLC - Deerfield Beach
- Bruce A. Segal, MD - Delray Beach
- International Research Center - Tampa
Alabama
- Trinity Research Group - Dothan
Arizona
- Horizon Eye Specialists & LASIK Center - Sun City
Kentucky
- The Eye Care Institute - Louisville
Nevada
- Center for Sight - Henderson
South Dakota
- Vance Thompson Vision - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What the registry record for NCT05456425 still lists
NCT05456425 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 3 other Pterygium trials with a reported enrollment target (1335% higher).
The record links to 1 condition, with Pterygium appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT05456425 names 20 study sites across 9 states, led by California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT05456425 about?
NCT05456425 is a clinical study titled "A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium". 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.
What is the current status of trial NCT05456425?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2022-06-30. Estimated completion is 2027-12-31.
What conditions does trial NCT05456425 study?
This clinical trial studies the following conditions: Pterygium.
What interventions are being tested in trial NCT05456425?
The interventions under investigation include: Vehicle (DRUG), CBT-001 (DRUG).
Who is sponsoring clinical trial NCT05456425?
This trial is sponsored by Cloudbreak Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05456425 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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