Back to resultsEfficacy and Tolerability of Blephademodex Wipes
Primary Purpose
Demodex Blepharitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Blephademodex
Sponsored by
About this trial
This is an interventional treatment trial for Demodex Blepharitis
Eligibility 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
Sites / Locations
- Consultation office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-arm
Arm Description
Outcomes
Primary Outcome Measures
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?
Global Discomfort Score
Change from D28 at Day 56
Secondary Outcome Measures
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?
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.
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".
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)
Ocular surface redness
Efron scale
Lid margin redness/swelling
Efron/custom scale
Cylindrical dandruff
Lash line coverage (%) and severity (mild/moderate/severe)
Ocular surface staining
Oxford scale; corneal only
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)
Tolerability of the wipes
Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)
Visual acuity
Snellen eye chart
Assessment of ease of use
as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04780165
Brief Title
Efficacy and Tolerability of Blephademodex Wipes
Official Title
Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Demodex Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Blephademodex
Other Intervention Name(s)
Blephaclean
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Discomfort Score
Description
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
Title
Global Discomfort Score
Description
Change from D28 at Day 56
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Specific Blepharitis symptoms
Description
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
Title
adapted Total Ocular Symptom Score (TOSS)
Description
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
Title
Symptom Assessment in Dry Eye (SANDE)
Description
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
Title
Demodex count
Description
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
Title
Ocular surface redness
Description
Efron scale
Time Frame
Day 56
Title
Lid margin redness/swelling
Description
Efron/custom scale
Time Frame
Day 56
Title
Cylindrical dandruff
Description
Lash line coverage (%) and severity (mild/moderate/severe)
Time Frame
Day 56
Title
Ocular surface staining
Description
Oxford scale; corneal only
Time Frame
Day 56
Title
Physician's impression and patient impression
Description
Answer the item 'the treatment has been sufficiently effective' on a 4-point scale (strongly disagree, disagree, agree, strongly agree)
Time Frame
Day 56
Title
Tolerability of the wipes
Description
Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)
Time Frame
Day 56
Title
Visual acuity
Description
Snellen eye chart
Time Frame
Day 56
Title
Assessment of ease of use
Description
as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".
Time Frame
Day 56
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Consultation office
City
Heidelberg
ZIP/Postal Code
69121
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Tolerability of Blephademodex Wipes
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