CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 421 enrolled
Drug / intervention
TP-03, 0.25% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04475432
NCT04475432Phase 3Completed
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Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Tarsus Pharmaceuticals, Inc.·interventional·Posted Jul 17, 2020·Updated Dec 21, 2023

In Brief

A Phase 3 clinical trial evaluating TP-03, 0.25% and TP-03 Vehicle for Blepharitis. Completed, enrolled 421 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlepharitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 17, 2020
Enrollment StartSep 9, 2020
Primary CompletionMay 4, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.0 years ago

Interventions

TP-03, 0.25%drug

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

TP-03 Vehicledrug

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