NCT05629390

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

Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: LianBio LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

The main study is designed to demonstrate the superiority of TP-03 compared to vehicle for the treatment of Demodex blepharitis in Chinese patients. The vehicle of TP-03 was selected as the control since there are no approved pharmaceutical treatments for Demodex blepharitis. The vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone. A pharmacokinetics (PK) sub-study is included in the overall study design to evaluate systemic PK parameters of TP-03 in Chinese participants with Demodex blepharitis. The PK sub-study sites are separate from those of the Phase III study as described above.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	Lotilaner	Lotilaner Ophthalmic Solution
DRUG	Vehicle Control	Vehicle of TP-03 ophthalmic solution

Timeline

• Start date: 2022-10-23
• Primary completion: 2023-09-15
• Completion: 2024-04-02
• First posted: 2022-11-29
• Last updated: 2024-05-21

Locations

21 sites across 1 country: China