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

September 11, 2025 updated by: Tarsus Pharmaceuticals, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Northridge, California, United States, 91325
        • Mitchell C. Shultz, MD
    • Missouri
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Center
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • Oculus Research
      • Shelby, North Carolina, United States, 28150
        • CORE Inc.
    • Pennsylvania
      • New Freedom, Pennsylvania, United States, 17349
        • Medical Optometry America

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BID Dosing
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days
Drug: TP-03
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
Drug: TP-03 Vehicle
Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms
Experimental: TID Dosing
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
Drug: TP-03
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
85 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 85 visit
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).
Day 85 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mitchell Shultz, MD, Mitchell C. Shultz, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRS-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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