XDEMVY Eye Drops for Blepharitis
(Ariel Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byBlake Simmons, OD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Tarsus Pharmaceuticals, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Demodex blepharitis, a type of eyelid inflammation. Participants must be willing to follow the study rules and have certain symptoms like collarettes on eyelashes and redness of the lower eyelid. They should also wear soft contact lenses regularly and agree to continue wearing them during the study.

Inclusion Criteria

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

My eye condition meets specific health criteria.

I am willing and able to follow the study rules and sign the consent form.

Exclusion Criteria

I have used XDEMVY eye drops in the last year.

Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment

Currently pregnant or lactating

+4 more

Participant Groups

The trial is testing XDEMVY ophthalmic drops against a vehicle control (a similar solution without the active drug) to see if it's effective in treating Demodex blepharitis and improving comfort for soft contact lens wearers.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 Intervention

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

Group II: ControlPlacebo Group1 Intervention

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