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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Demodex Blepharitis
Intervention / Treatment

-

Contacts and Locations

Cave Creek

Site, Cave Creek, Arizona, United States, 85331

Long Beach

Site, Long Beach, California, United States, 90805

Colorado Springs

Vision Institute, Colorado Springs, Colorado, United States, 80907

Delray Beach

Site, Delray Beach, Florida, United States, 33484

Indianapolis

Site, Indianapolis, Indiana, United States, 46240

Pittsburg

Site, Pittsburg, Kansas, United States, 66762

Louisville

Site, Louisville, Kentucky, United States, 40206

Edina

Site, Edina, Minnesota, United States, 55436

Shelby

Site, Shelby, North Carolina, United States, 28150

Fargo

Site, Fargo, North Dakota, United States, 58103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tarsus Pharmaceuticals, Inc.,

Blake Simmons, OD, PRINCIPAL_INVESTIGATOR, Vision Institute

Study Record Dates

2024-12