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

NCT06054217 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: TRS-021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Demodex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in lower lid meibomian gland secretion score

  85 days

• Change from baseline in lid margin erythema.

  85 days

• Change from baseline in tear breakup time assessed via slit lamp

  85 days

Study Arms (3)

Study Cohort 1

EXPERIMENTAL

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

Study Cohort 2

EXPERIMENTAL

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

Drug: Vehicle of TP-03

Study Cohort 3

EXPERIMENTAL

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

Drug: Vehicle of TP-03

Interventions

Vehicle of TP-03 DRUG

The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)

Also known as: Exploratory Vehicle

Study Cohort 1; Study Cohort 2; Study Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 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

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 (2)

Shultz Chang Vision

Northridge, California, 91325, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Mitchell C Shultz, MD

  Shultz Chang Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: August 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)