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

Tarsus Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Blepharitis; Demodex Infestation of Eyelid; Demodectic Blepharitis; Meibomian Gland Dysfunction

Treatments: Drug: Vehicle of TP-03

Study type: Interventional

Funder types: Industry

Identifiers

NCT06054217

TRS-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Study Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Vehicle of TP-03

Study Cohort 2

Experimental group

Description:

Participants are randomized to receive BID administration of EV for approximately 85 days.

Treatment:

Drug: Vehicle of TP-03

Study Cohort 3

Experimental group

Description:

Participants are randomized to receive TID administration of EV for approximately 85 days

Treatment:

Drug: Vehicle of TP-03