COMPLETED

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

Talk to us

Conditions

Demodex BlepharitisSoft contact lenses

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-27
Study Completion:2025-01-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06182358

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
  2. * 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
  3. * 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
  1. * 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
  2. * 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
  3. * 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
  4. * Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
  5. * 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
  6. * Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment
  7. * Currently pregnant or lactating

Contacts and Locations

Principal Investigator

Blake Simmons, OD
PRINCIPAL_INVESTIGATOR
Vision Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Tarsus Pharmaceuticals, Inc.

  • Blake Simmons, OD, PRINCIPAL_INVESTIGATOR, Vision Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27
Study Completion Date2025-01-27

Study Record Updates

Study Start Date2023-12-27
Study Completion Date2025-01-27

Terms related to this study

Keywords Provided by Researchers

  • Soft contact lenses

Additional Relevant MeSH Terms

  • Demodex Blepharitis