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Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

NCT04475432 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2023-12-21

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.

Conditions

  • Blepharitis

Interventions

DRUG

TP-03, 0.25%

TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day

DRUG

TP-03 Vehicle

Vehicle of TP-03 ophthalmic solution, administered twice a day

Sponsors & Collaborators

  • Tarsus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wirta, MD · Eye Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-05-04
Completion
2021-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04475432 on ClinicalTrials.gov