CompletedNot Applicable

Efficacy and Tolerability of Blephademodex Wipes

Germany50 participantsStarted 2019-09-11

Plain-language summary

Primary Objective \- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS). Secondary Objectives * To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only) * To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes * To evaluate ease of use for Blephademodex eyelid hygiene wipes * Adverse events are documented and analyzed.

Who can participate

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: * Patient \> 18 years old, all genders * Able to read, to write and to fully understand German language * Good general health as determined by the investigator by medical history and physical appearance * Provision of written informed consent prior to inclusion * Moderate to Severe Blepharitis - grade ≥ 2 (Efron Scale) * Global discomfort score (GDS) ≥ 4 * Proof of demodex infestation by at least ONE of the following:Demodex visible after lash manipulation;Cylindrical dandruff along the lash line; Lid margin itching; Madarosis Exclusion Criteria: * History of ocular trauma, ocular infection or intra-ocular inflammation within the 3 months before screening visit * History of ocular refractive surgery and any other ocular surgeries within 3 months before screening visit * History of ocular allergy or ocular herpes within the 3 months before screening visit * History of inflammatory corneal ulcer within the 6 months before screening visit * Sjogren syndrome or any other rheumatologic disease related dry eye * Concurrent treatment with other eye drops (anti-infectives, steroids, prostaglandins (but artificial tears are ok). * Specific Exclusion Criteria for Women:Patient who verbally confirms pregnancy or lactation; Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch or condom) and is not surgically sterilised

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

Global Discomfort Score

Timeframe: Day 28

Global Discomfort Score

Timeframe: Day 56

Trial details

NCT IDNCT04780165

SponsorLaboratoires Thea

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-13

View on ClinicalTrials.gov More Demodex Blepharitis trials

Plain-language summary

Who can participate

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.