drugset / Trial / NCT05629390
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The Phase III main study is a randomized, controlled, multicenter, double blind, trial to evaluate the efficacy and safety of TP-03 (lotilaner ophthalmic solution, 0.25%), for the treatment of Demodex blepharitis in Chinese patients. The PK sub-study is a single-arm, open-label trial to evaluate systemic TP-03 in whole blood following topical ocular administration
Timeline
- Start
- 2022-10-23
- Primary completion
- 2023-09-15
- Completion
- 2024-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lotilaner | Small molecule | 0.25 % | Topical |