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

Meibomian Gland Dysfunction Clinical Trial

— Rhea  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06054217
• Other study ID #: TRS-021
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: April 2024
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Meibomian Gland Dysfunction
• Parasitic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Shultz Chang Vision	Northridge	California
United States	Vita Eye Clinic	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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