Clinical trial NCT06182358: Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
Official title: Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Demodex Blepharitis
Keywords: Soft contact lenses
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active arm: XDEMVY 0.25% Control arm: Vehicle of XDEMVY
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of collarettes at Day 43
timeFrame: 43 days
Secondary outcomes:
measure: Reduction of eyelid margin erythema at Day 43
timeFrame: 43 days
measure: Subject-reported comfortable daily wear time
timeFrame: 43 days
measure: Total contact lens wear time
timeFrame: 43 days
Other outcomes:
Locations:
city: Cave Creek
country: United States
facility: Site
state: Arizona
city: Long Beach
country: United States
facility: Site
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Delray Beach
country: United States
facility: Site
state: Florida
city: Indianapolis
country: United States
facility: Site
state: Indiana
city: Pittsburg
country: United States
facility: Site
state: Kansas
city: Louisville
country: United States
facility: Site
state: Kentucky
city: Edina
country: United States
facility: Site
state: Minnesota
city: Shelby
country: United States
facility: Site
state: North Carolina
city: Fargo
country: United States
facility: Site
state: North Dakota
city: Powell
country: United States
facility: Site
state: Ohio
city: Cranberry Township
country: United States
facility: Site
state: Pennsylvania
city: Memphis
country: United States
facility: Site
state: Tennessee
city: Houston
country: United States
facility: Site
state: Texas
Study officials:
affiliation: Vision Institute
name: Blake Simmons, OD
role: PRINCIPAL_INVESTIGATOR
References: