Efficacy and Tolerability of Blephademodex Wipes

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

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 Overview

• Status: Completed
• Conditions: Demodex Blepharitis
• Intervention / Treatment: Device: Blephademodex

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69121
    • Consultation office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Blephaclean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	Day 28
Global Discomfort Score	Change from D28 at Day 56	Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	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.	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".	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)	Day 56
Ocular surface redness	Efron scale	Day 56
Lid margin redness/swelling	Efron/custom scale	Day 56
Cylindrical dandruff	Lash line coverage (%) and severity (mild/moderate/severe)	Day 56
Ocular surface staining	Oxford scale; corneal only	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)	Day 56
Tolerability of the wipes	Tolerability assessment by the physician and patient (0 = intolerable; 1 = somewhat tolerable; 2 = tolerable; 3 = fully tolerable)	Day 56
Visual acuity	Snellen eye chart	Day 56
Assessment of ease of use	as experienced by the subjects, rated on a five-point scale of "Very Difficult" to "Very Easy".	Day 56

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): May 14, 2020

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis
• Other Study ID Numbers: LTPIVBDX19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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