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NCT03049852 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
A Phase 2 study, sponsored by Cloudbreak Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT03049852: Completed Phase 2 study, sponsored by Cloudbreak Therapeutics.
NCT03049852 is a Phase 2 study that has completed, run by Cloudbreak Therapeutics. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03049852, a Phase 2 study, has completed, sponsored by Cloudbreak Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24) Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)
Primary Outcome
The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.
Interventions
- DRUG Vehicle
- DRUG CBT-001 single dose
- DRUG CBT-001 Multi-dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-04-15 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
What the finished NCT03049852 record still lists
NCT03049852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT03049852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03049852 about?
NCT03049852 is a clinical study titled "Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium". Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24) Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)
What is the current status of trial NCT03049852?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-04-15. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT03049852?
The interventions under investigation include: Vehicle (DRUG), CBT-001 single dose (DRUG), CBT-001 Multi-dose (DRUG).
Who is sponsoring clinical trial NCT03049852?
This trial is sponsored by Cloudbreak Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03049852's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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