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

NCT ID: NCT05454956

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2023-05-18

Brief 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.

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.

Conditions

Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

TP-03

Intervention Type: 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

Intervention Type: DRUG

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

TID Dosing

TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days

Group Type: EXPERIMENTAL

TP-03

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarsus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Shultz, MD

Role: PRINCIPAL_INVESTIGATOR

Mitchell C. Shultz, MD

Locations

Mitchell C. Shultz, MD

Northridge, California, United States

Silverstein Eye Center

Kansas City, Missouri, United States

Oculus Research

Cary, North Carolina, United States

CORE Inc.

Shelby, North Carolina, United States

Medical Optometry America

New Freedom, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TRS-008

Identifier Type: -

Identifier Source: org_study_id