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OpenTrials
Completed

NCT Number: NCT04780165

Efficacy and Tolerability of Blephademodex Wipes

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.

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Key information

Conditions

Demodex Blepharitis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consultation office

Heidelberg, 69121, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blephademodex

Device

During the first 28 days of the trial, subjects will use one Blephademodex® eyelid hygiene wipe every evening per eye to clean the eyelids of both their eyes. At the start of the second period the Investigator will assess based on the GDS if the condition is resolved and manage accordingly: subjects will either continue with this regime if GDS is unchanged (further treatment phase) or revert to Blephaclean wipes every evening instead (maintenance phase), again to clean the eyelids of both their eyes.

Other names: Blephaclean

Primary outcomes

  1. Global Discomfort Score

    Time frame: Day 28

    Change from Baseline at Day 28 The Global (overall) discomfort score (GDS) consists of a single question, which can be answered by the subject by choosing a value between 0 (no discomfort) and 10 (worst discomfort): Thinking about today, how would you rate the discomfort of your eyes?

  2. Global Discomfort Score

    Time frame: Day 56

    Change from D28 at Day 56

Secondary outcomes

  1. Specific Blepharitis symptoms

    Time frame: Day 56

    Symptoms will be rated by the patient on the day of visit using 10-grade scales (0 = none to 10 = severe) for each of the following items Severity of any eyelid itching today / Severity of lid redness today / Severity of eyelid swelling today / How severe was the eyelid crusting this morning when you woke up? / How severe is missing lashes today?

  2. adapted Total Ocular Symptom Score (TOSS)

    Time frame: Day 56

    8-item questionnaire with an overall score ranging from 0 ("none of the time") to 4 ("all of the time"). It contains of a single question concerning the frequency with which 8 different symptoms (itchy eyelids, eyelid redness, red eyes generally, swollen (puffy) eyes, tearing (eyes watering), crusting around the lashes, burning or stinging sensations and noticed eyelash loss) were experienced in the course of a week.

  3. Symptom Assessment in Dry Eye (SANDE)

    Time frame: Day 56

    Comprised of two questions: 1) How often do your eyes feel dry and/or irritated? And 2) How severe you feel your symptoms of dryness and/or irritation are? This questionnaire uses a 100 mm horizontal line as visual analogue scale (VAS) for each question to assess ocular discomfort and/or dryness experienced by the patients. In the SANDE questionnaire, frequency of symptoms ranges from "rarely" to "all of the time" and the severity of symptoms ranges from "very mild" to "very severe".

  4. Demodex count

    Time frame: Day 56

    Sideways 'pull' on 10 eyelashes - upper or lower lashes Extent (mites present? yes or no) and Severity/Intensity (1=1 tail; 2=2 tails; 3 =2+tails)

  5. Ocular surface redness

    Time frame: Day 56

    Efron scale

  6. Lid margin redness/swelling

    Time frame: Day 56

    Efron/custom scale

  7. Cylindrical dandruff

    Time frame: Day 56

    Lash line coverage (%) and severity (mild/moderate/severe)

  8. Ocular surface staining

    Time frame: Day 56

    Oxford scale; corneal only

  9. Physician's impression and patient impression

    Time frame: Day 56

    Answer the item 'the treatment has been sufficiently effective' on a 4-point scale (strongly disagree, disagree, agree, strongly agree)

  10. Tolerability of the wipes

    Time frame: Day 56

    Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)

  11. Visual acuity

    Time frame: Day 56

    Snellen eye chart

  12. Assessment of ease of use

    Time frame: Day 56

    as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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