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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Consultation office
Heidelberg, Germany
Global Discomfort Score
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?
Time frame: Day 28
Global Discomfort Score
Change from D28 at Day 56
Time frame: Day 56
Specific Blepharitis symptoms
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?
Time frame: Day 56
adapted Total Ocular Symptom Score (TOSS)
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.
Time frame: Day 56
Symptom Assessment in Dry Eye (SANDE)
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".
Time frame: Day 56
Demodex count
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)
Time frame: Day 56
Ocular surface redness
Efron scale
Time frame: Day 56
Lid margin redness/swelling
Efron/custom scale
Time frame: Day 56
Cylindrical dandruff
Lash line coverage (%) and severity (mild/moderate/severe)
Time frame: Day 56
Ocular surface staining
Oxford scale; corneal only
Time frame: Day 56
Physician's impression and patient impression
Answer the item 'the treatment has been sufficiently effective' on a 4-point scale (strongly disagree, disagree, agree, strongly agree)
Time frame: Day 56
Tolerability of the wipes
Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)
Time frame: Day 56
Visual acuity
Snellen eye chart
Time frame: Day 56
Assessment of ease of use
as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".
Time frame: Day 56
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