Clinical trial NCT06054217: Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
Official title: Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Demodex Infestation of Eyelid
Blepharitis
Demodectic Blepharitis
Keywords: Demodex
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: 85 days
Secondary outcomes:
measure: Change from baseline in lower lid meibomian gland secretion score
timeFrame: 85 days
measure: Change from baseline in lid margin erythema.
timeFrame: 85 days
measure: Change from baseline in tear breakup time assessed via slit lamp
timeFrame: 85 days
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Shultz Chang Vision
state: California
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
Study officials:
affiliation: Shultz Chang Vision
name: Mitchell C Shultz, MD
role: PRINCIPAL_INVESTIGATOR
References: