Blepharitis, Demodectic Blepharitis, Demodex Infestation of Eyelid, Meibomian Gland Dysfunction
Conditions
Keywords
Demodex
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.
Interventions
DRUGVehicle of TP-03
The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)
Sponsors
Tarsus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed