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

Demodex Blepharitis Clinical Trial

— Ariel  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182358
• Other study ID #: TRS-023
• Status: Recruiting
• Phase: Phase 4
• Start date: December 27, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: Jen Anderson
• Phone: 480-299-3918
• Email: JAnderson[@]tarsusrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Demodex Blepharitis

Intervention

Drug:
• Lotilaner ophthalmic solution, 0.25%
XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
• Vehicle control
Vehicle of XDEMVY administered topically twice a day for approximately 43 days

Locations

Country	Name	City	State
United States	Site	Cave Creek	Arizona
United States	Vision Institute	Colorado Springs	Colorado
United States	Site	Cranberry Township	Pennsylvania
United States	Site	Delray Beach	Florida
United States	Site	Edina	Minnesota
United States	Site	Fargo	North Dakota
United States	Site	Houston	Texas
United States	Site	Indianapolis	Indiana
United States	Site	Long Beach	California
United States	Site	Louisville	Kentucky
United States	Site	Memphis	Tennessee
United States	Site	Pittsburg	Kansas
United States	Site	Powell	Ohio
United States	Site	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Subject-reported comfortable daily wear time	Comfortable daily wear time in hours per day	43 days
Secondary	Total contact lens wear time	Total daily wear time in hours per day	43 days