Skip to main content
OpenTrials
Completed

NCT Number: NCT05454956

Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Meibomian Gland Dysfunction Blepharitis Demodex Infestation Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mitchell C. Shultz, MD, Northridge, California, United States

Loading trial locations.

About this study

This Phase 2a study is a randomized, two-arm, double-masked, multicenter, parallel pilot study to compare the safety and efficacy of two dosing regimens of TP-03, BID vs TID, for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation. The primary objective of the study is to assess the safety and efficacy of two dosing regimens of TP-03, 0.25% from Day 1 to Day 85 in adult participants with meibomian gland dysfunction in the presence of Demodex infestation. Efficacy will be determined by assessing lower lid meibomian gland secretion, lid margin erythema, bulbar redness, tear breakup time, ocular surface staining, and dry eye symptoms. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity and slit lamp biomicroscopy from baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
  • Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites in the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid

Exclusion criteria

  • Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study
  • Have used systemic antihistamines within 30 days of Day 1
  • Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study
  • Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study
  • Be pregnant or lactating at Day 1

Treatment and study plan

TP-03

Drug

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 Vehicle

Drug

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

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 85 days

    Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.

Other outcomes

  1. Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85

    Time frame: Day 85 visit

    For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45

  2. Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85

    Time frame: Day 85 visit

    Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe).

Sponsors and collaborators

Lead sponsor

Tarsus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: Ersa

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.