CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
TP-03 +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/NCT05454956
NCT05454956Phase 2Completed
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Randomized, Double-Masked, Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

Tarsus Pharmaceuticals, Inc.·interventional·Posted Jul 12, 2022·Updated Oct 1, 2025

In Brief

A Phase 2 clinical trial evaluating TP-03 and TP-03 Vehicle for Meibomian Gland Dysfunction and 2 related conditions. Completed, enrolled 39 participants across 5 sites.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, BID vs TID dosing regimens for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeibomian Gland Dysfunction, Blepharitis, Demodex Infestation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 12, 2022
Enrollment StartAug 3, 2022
Primary CompletionMay 18, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.0 years ago

Interventions

TP-03drug

TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm

TP-03 Vehicledrug

Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms