UnknownPhase 1

Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%

United States20 participantsStarted 2021-08-24

Plain-language summary

Patients with Demodex infestation of the eyelids will have the sleeves from both eyes cleaned off with microblepharoexfoliation. Afterwards, one eye will be randomly selected for treatment with topical ivermectin 1% cream. The treatment will be repeated on that eye 2 weeks later. Afterwards, the patients will present monthly for photographs of the eyelashes. The photographs will be reviewed by an ophthalmologist outside of our institution who will be blind to which eye was treated and independently grade the amount of sleeves in each eye. The follow-up will be for 6 months after the second treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Voluntary participation of subjects with moderate to dense sleeves with no allergy to ivermectin and the ability to keep follow-up appointments. \- Exclusion Criteria: Patients under 18 years old and those allergic to ivermectin. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparative density of sleeves

Timeframe: Each patient will be followed for 6 months.

Trial details

NCT IDNCT05213585

SponsorHelm Vision Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-30

Contact for this trial

Craig J Helm, MD

6617132575 craighelm@sbcglobal.net

View on ClinicalTrials.gov More The Focus of the Study is to Assess the Effectiveness of Topical Ivermectin on Eliminating Eyelash Sleeves trials