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

Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

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.

Study Overview

• Status: Recruiting
• Conditions: Demodex Blepharitis
• Intervention / Treatment: Drug: Lotilaner ophthalmic solution, 0.25%; Drug: Vehicle control

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jen Anderson; Phone Number: 480-299-3918; Email: JAnderson@tarsusrx.com

Study Locations

• United States
  • Arizona
    • Cave Creek, Arizona, United States, 85331
      • Recruiting
      • Site
  • California
    • Long Beach, California, United States, 90805
      • Recruiting
      • Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Recruiting
      • Vision Institute
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Recruiting
      • Site
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Recruiting
      • Site
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Recruiting
      • Site
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Recruiting
      • Site
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Recruiting
      • Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • Recruiting
      • Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Recruiting
      • Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Site
  • Texas
    • Houston, Texas, United States, 77005
      • Recruiting
      • Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days	Drug: Lotilaner ophthalmic solution, 0.25%; XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
Placebo Comparator: Control; Vehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days	Drug: Vehicle control; Vehicle of XDEMVY administered topically twice a day for approximately 43 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of collarettes at Day 43	Change in collarette score at Day 43 compared to baseline, graded from 0 (0 to 2 lashes have collarettes per eyelid) to 4 ( 2/3 or more of lashes have collarettes per eyelid)	43 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of eyelid margin erythema at Day 43	Change in eyelid margin erythema score at Day 43 compared to baseline, graded from 0 (normal) to 3 (severe)	43 days
Subject-reported comfortable daily wear time	Comfortable daily wear time in hours per day	43 days
Total contact lens wear time	Total daily wear time in hours per day	43 days

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Blake Simmons, OD, Vision Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Soft contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: TRS-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes