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Anti-parasitic

Active Treatment for Demodex 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

Ariel Trial 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.Check my eligibility
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.See study design
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.

Ariel Trial 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

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

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Pharyngitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

Ariel 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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At present, how many locations are hosting this particular clinical trial?

"The current trial is operational at 14 locations, including Edina, Long Beach, and Colorado Springs among others. Opting for the nearest site when enrolling can help reduce travel requirements."

Answered by AI

Is the enrollment process currently open for this clinical trial?

"Indeed, data available on clinicaltrials.gov highlights the ongoing recruitment of participants for this trial. This particular clinical study was first uploaded on December 27th, 2023 and most recently revised on March 22nd, 2024. The aim is to enroll a total of 166 patients across fourteen different sites."

Answered by AI

What is the current number of participants involved in this clinical investigation?

"Indeed, data available on clinicaltrials.gov confirms the ongoing recruitment of participants for this investigation. The trial was initially published on December 27th, 2023, and last revised on March 22nd, 2024. In total, 166 individuals are sought across a network of 14 research sites."

Answered by AI

Are individuals above the age of 45 eligible to participate in this study?

"To be eligible for this research study, individuals must be at least 18 years old but no older than 70."

Answered by AI

Has the FDA granted approval for Active Treatment?

"Our team considers Active Treatment to be very safe, rating it as a 3 on our scale. This is due to its Phase 4 status, indicating that the treatment has already received approval."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
2023. "Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182358.
All > Blepharitis > Colorado Springs
~106 spots leftby Dec 2024
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