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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-27

Study Completion Date

2025-01-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Demodex Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active arm: XDEMVY 0.25% Control arm: Vehicle of XDEMVY

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Treatment assignment will be unknown to the study participants, investigators, and site staff performing study assessments

Study Groups

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Active Treatment

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

Group Type EXPERIMENTAL

Lotilaner ophthalmic solution, 0.25%

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Vehicle control

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No