Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers (Ariel)

Tarsus Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Demodex Blepharitis

Treatments: Drug: Vehicle control; Drug: Lotilaner ophthalmic solution, 0.25%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06182358

TRS-023

Details and patient eligibility

About

To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

Full description

This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
• Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid
• Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study

Exclusion criteria

• Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study
• Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
• Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study
• Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
• Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study
• Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment
• Currently pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Active Treatment

Experimental group

Description:

XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days

Treatment:

Drug: Lotilaner ophthalmic solution, 0.25%

Control

Placebo Comparator group

Description:

Vehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days

Treatment:

Drug: Vehicle control