drugset / Trial / NCT05629390

Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

NCT05629390 ↗

Phase 3 Completed 163 enrolled LianBio LLC
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

EvaluationDrugModalityDoseRoute
Subject lotilaner Small molecule 0.25 % Topical

Indications