CompletedPhase 4

Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine

Mexico106 participantsStarted 2024-07-01

Plain-language summary

This study employed an experimental, prospective, longitudinal, before-and-after design to evaluate the efficacy of topical chlorhexidine wipes in treating blepharitis. The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye. Each subject underwent an assessment of the Demodex Folliculorum infection index through the epilation of four eyelashes, followed by direct visualization using optical microscopy. Additionally, the number of eyelashes with collarettes was categorized and graded as follows: Grade 0: 0-2 eyelashes per eyelid with collarettes; Grade 1: 3-10 eyelashes per eyelid with collarettes; Grade 2: ≥10 to ≤1/3; Grade 3: ≥1/3 - ≤2/3; Grade 4: ≥2/3 of eyelashes per eyelid with collarettes. Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

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: * Age ≥ 18 years * Clinical diagnosis of Demodex folliculorum blepharitis * Presence of eyelash collarettes on slit-lamp examination * Positive identification of Demodex folliculorum by epilation of 4 upper and 4 lower eyelashes per eyelid and visualization under light microscopy * Willingness to use chlorhexidine eyelid wipes as instructed for 8 weeks Exclusion Criteria: * Use of topical or systemic antiparasitic treatment within the past 6 weeks * Use of topical ophthalmic antibiotics or anti-inflammatory medication within the past 6 weeks * Known allergy or hypersensitivity to chlorhexidine * Pregnancy or breastfeeding

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

Reduction in Demodex folliculorum count per eyelash

Timeframe: Baseline and 8 weeks

Trial details

NCT IDNCT07451678

SponsorInstituto de Oftalmología Fundación Conde de Valenciana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Blepharitis trials