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Efficacy and Tolerability of Blephademodex Wipes

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ClinicalTrials.gov Identifier: NCT04780165
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Brief 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.

Condition or disease Intervention/treatment Phase
Demodex Blepharitis Device: Blephademodex Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis
Actual Study Start Date : September 11, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : May 14, 2020

Arm Intervention/treatment
Experimental: Single-arm Device: Blephademodex
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 Name: Blephaclean




Primary Outcome Measures :
  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 Outcome Measures :
  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".



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780165


Locations
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Germany
Consultation office
Heidelberg, Germany, 69121
Sponsors and Collaborators
Laboratoires Thea
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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT04780165    
Other Study ID Numbers: LTPIVBDX19
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases