drugset / Trial / NCT05372991
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
Phase 1/2
Completed
84 enrolled
Cloudbreak Therapeutics, LLC
Novotech (Australia) Pty Limited · collab
RandomizedSequentialDouble-blindTreatment
Summary
This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. CBT-009 has the active ingredient of atropine, which at low doses, has shown to be effective in slowing down myopic deterioration. Current atropine products are prone to degradation once the container is open to the air. ADS Pharmaceutical has developed a novel atropine formulation.
Timeline
- Start
- 2022-07-20
- Primary completion
- 2023-01-18
- Completion
- 2023-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atropine | Other / unclassified | 0.025 % | Other |
| Subject | CBT-009 | Unknown | — | Other |