Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1% (NCT02236403) | Clinical Trial Compass
CompletedPhase 3
Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Colombia60 participantsStarted 2014-10
Plain-language summary
Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication.
In this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites
Who can participate
Age range
18 Years – 80 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:
* • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
* Age range: 18 yeras and older.
* Both genders and all ethnic groups comparable with the local community.
* Able to understand and willing to sign a written informed consent
* Able and willing to cooperate with the investigational plan.
* Able and willing to complete all mandatory follow-up visits.
Exclusion Criteria:
* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
* Children under 18.
* Pregnant women or expecting to be pregnant during the study.
* Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
* Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
* Concomitant use of systemic antibiotics or steroids.
* Contact lens wear
* Active ocular infection or allergy
* Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or 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.