Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
- Conditions
- Meibomian Gland DysfunctionDemodex Infestation of EyelidBlepharitisDemodectic Blepharitis
- Interventions
- Drug: Vehicle of TP-03
- Registration Number
- NCT06054217
- Lead Sponsor
- Tarsus Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Cohort 1 Vehicle of TP-03 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. Study Cohort 2 Vehicle of TP-03 Participants are randomized to receive BID administration of EV for approximately 85 days. Study Cohort 3 Vehicle of TP-03 Participants are randomized to receive TID administration of EV for approximately 85 days
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events (TEAEs) 85 days TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
- Secondary Outcome Measures
Name Time Method Change from baseline in lower lid meibomian gland secretion score 85 days 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).
Change from baseline in tear breakup time assessed via slit lamp 85 days Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Change from baseline in lid margin erythema. 85 days 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.
Trial Locations
- Locations (2)
Shultz Chang Vision
🇺🇸Northridge, California, United States
Vita Eye Clinic
🇺🇸Shelby, North Carolina, United States