Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex

Last updated: April 6, 2024
Sponsor: Tarsus Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Dry Eyes

Dry Eye Disease

Blepharitis

Treatment

Vehicle of TP-03

Exploratory Vehicle

Clinical Study ID

NCT06054217
TRS-021
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Be willing to sign the informed consent and deemed capable of complying with therequirements of the study protocol
  • Meets all of the following criteria in at least one eye: have more than 10 lashes withcollarettes present on the upper lid; have the presence of one or more mites with lashepilation of 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 10seconds; and have intact partial to full meibomian glands in at least 33% of the totalmeibomian gland area of the lower lid

Exclusion

Key Exclusion Criteria:

  • Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the useof 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 oreyelid procedures within 7 days of Day 1 or be unwilling to forego their use duringthe study
  • Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear forthe duration of the study
  • Be pregnant or lactating at Day 1

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Vehicle of TP-03
Phase: 2
Study Start date:
August 01, 2023
Estimated Completion Date:
June 15, 2024

Study Description

This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.

Connect with a study center

  • Shultz Chang Vision

    Northridge, California 91325
    United States

    Site Not Available

  • Vita Eye Clinic

    Shelby, North Carolina 28150
    United States

    Site Not Available

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