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

Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation of Eyelid; Demodectic Blepharitis
• Intervention / Treatment: Drug: Vehicle of TP-03

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Northridge, California, United States, 91325
      • Shultz Chang Vision
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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 with lash epilation 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 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid

Key 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Cohort 1; Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days.	Drug: Vehicle of TP-03; The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%); Other Names: Exploratory Vehicle
Experimental: Study Cohort 2; Participants are randomized to receive BID administration of EV for approximately 85 days.	Drug: Vehicle of TP-03; The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%); Other Names: Exploratory Vehicle
Experimental: Study Cohort 3; Participants are randomized to receive TID administration of EV for approximately 85 days	Drug: Vehicle of TP-03; The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%); Other Names: Exploratory Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.	85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in lid margin erythema.	Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.	85 days
Change from baseline in lower lid meibomian gland secretion score	For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).	85 days
Change from baseline in tear breakup time assessed via slit lamp	Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.	85 days

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Mitchell C Shultz, MD, Shultz Chang Vision

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Demodex
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Blepharitis; Parasitic Diseases
• Other Study ID Numbers: TRS-021

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