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

NCT06182358 | Completed Phase 4 FDA Drug

• 1 other identifier: TRS-023
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 14

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.

Conditions

Demodex Blepharitis

Keywords

Soft contact lenses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction of eyelid margin erythema at Day 43

  43 days

• Subject-reported comfortable daily wear time

  43 days

• Total contact lens wear time

  43 days

Study Arms (2)

Active Treatment

EXPERIMENTAL

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

Drug: Lotilaner ophthalmic solution, 0.25%

Control

PLACEBO COMPARATOR

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

Drug: Vehicle control

Interventions

Lotilaner ophthalmic solution, 0.25% DRUG

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

Active Treatment

Vehicle control DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (14)

Site

Cave Creek, Arizona, 85331, United States

Location

Site

Long Beach, California, 90805, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Site

Delray Beach, Florida, 33484, United States

Location

Site

Indianapolis, Indiana, 46240, United States

Location

Site

Pittsburg, Kansas, 66762, United States

Location

Site

Louisville, Kentucky, 40206, United States

Location

Site

Edina, Minnesota, 55436, United States

Location

Site

Shelby, North Carolina, 28150, United States

Location

Site

Fargo, North Dakota, 58103, United States

Location

Site

Powell, Ohio, 43065, United States

Location

Site

Cranberry Township, Pennsylvania, 16066, United States

Location

Site

Memphis, Tennessee, 38104, United States

Location

Site

Houston, Texas, 77005, United States

Location

Study Officials

• Blake Simmons, OD

  Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment assignment will be unknown to the study participants, investigators, and site staff performing study assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: December 27, 2023
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)