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Eye drop aims to zap mites and boost lens comfort

NCT ID NCT07561450

Symptom relief Sponsor: Boston Sight Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether Xdemvy eye drops can reduce eyelash mite irritation and improve comfort for people who wear special scleral lenses. Five adult lens users with moderate to severe Demodex blepharitis will use the drops and report changes in symptoms like dryness, itching, and lens tolerance. The goal is to see if killing the mites leads to better lens wear and fewer eye problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:. 1. Written Informed Consent has been obtained prior to any study-related procedures taking place 2. Subject is Male or Female, 18 years of age or older prior to the initial visit 3. Is an established wearer of PROSE devices for \> 6 months in both eyes 4. Currently wears PROSE devices on a daily basis in both eyes 5. No plans to alter the PROSE lens design in either eye during the study period 6. Bilateral Demodex Blepharitis (\> Grade 2, which is more than 10 upper lash collarettes, worse eye) 7. Baseline CLDEQ-8 score of 12 or higher 8. Baseline VAS score of 40 or above for frequency OR severity in ONE of the following: tolerability, blurred vision, ocular burning, ocular redness or ocular itching 9. In the opinion of the investigator, the subject can follow study instructions 10. In the opinion of the investigator, the subject can complete all study procedures and visits \- Exclusion Criteria: 1. Is currently participating in any other type of eye-related clinical research study 2. Is pregnant or nursing as reported by the subject. 3. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study. 4. Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period. 5. Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks 6. The subject is only wearing a PROSE device in one eye. 7. The participant is monocular 8. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications 9. Allergy to sodium fluorescein 10. Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25% \-

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Conditions

The condition(s) this trial relates to.

blepharitis Demodex folliculitis demodicidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Demodex blepharitis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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More trials for these conditions

Other studies related to the condition(s) this trial covers.