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

NCT05454956 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TRS-008
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

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.

Conditions

Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation

Keywords

Demodex

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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

  85 days

Other Outcomes (2)

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

  Day 85 visit

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

  Day 85 visit

Study Arms (2)

BID Dosing

EXPERIMENTAL

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; Drug: TP-03 Vehicle

TID Dosing

EXPERIMENTAL

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

Drug: TP-03

Interventions

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

BID Dosing; TID Dosing

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

BID Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (5)

Mitchell C. Shultz, MD

Northridge, California, 91325, United States

Location

Silverstein Eye Center

Kansas City, Missouri, 64133, United States

Location

Oculus Research

Cary, North Carolina, 27513, United States

Location

CORE Inc.

Shelby, North Carolina, 28150, United States

Location

Medical Optometry America

New Freedom, Pennsylvania, 17349, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Kavita Dhamdhere, Vice President of Clinical Development
• Organization: Tarsus Pharmaceuticals, Inc.

kdhamdhere@tarsusrx.com

650-223-4062

Study Officials

• Mitchell Shultz, MD

  Mitchell C. Shultz, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment assignment (BID or TID) will be unknown to the study participant, investigators and site staff performing study assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Two doses of TP-03, 0.25% and one dose of TP-03 vehicle to maintain masking daily Arm 2: Three doses of TP-03, 0.25% daily

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 12, 2022
• Study Start: August 3, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)