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Anti-parasitic

XDEMVY Eye Drops for Blepharitis (Ariel Trial)

Phase 4
Recruiting
Led By Blake Simmons, OD
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 43 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare how well XDEMVY eye drops work compared to a control solution for treating Demodex blepharitis and how it affects the experience of wearing soft contact lenses.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not specified here, but generally, ophthalmic solutions can cause eye irritation, redness, discomfort or allergic reactions. The specific side effects will depend on how patients react to XDEMVY.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of collarettes at Day 43
Secondary study objectives
Reduction of eyelid margin erythema at Day 43
Subject-reported comfortable daily wear time
Total contact lens wear time

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

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

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Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,109 Total Patients Enrolled
Blake Simmons, ODPrincipal InvestigatorVision Institute
~0 spots leftby Dec 2024
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