MedTrace Logo

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

NCT05629390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2024-05-21

No results posted yet for this study

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

Conditions

  • Blepharitis

Interventions

DRUG

Lotilaner

Lotilaner Ophthalmic Solution

DRUG

Vehicle Control

Vehicle of TP-03 ophthalmic solution

Sponsors & Collaborators

  • LianBio LLC

    lead INDUSTRY

Principal Investigators

  • Zuguo Liu, M.D · Xiamen Eye Center of Xiamen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-23
Primary Completion
2023-09-15
Completion
2024-04-02

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629390 on ClinicalTrials.gov