Clinical trial NCT04780165: 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
Overall status: COMPLETED
Phase: NA
Conditions: Demodex Blepharitis
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Global Discomfort Score
timeFrame: Day 28
measure: Global Discomfort Score
timeFrame: Day 56
Secondary outcomes:
measure: Specific Blepharitis symptoms
timeFrame: Day 56
measure: adapted Total Ocular Symptom Score (TOSS)
timeFrame: Day 56
measure: Symptom Assessment in Dry Eye (SANDE)
timeFrame: Day 56
measure: Demodex count
timeFrame: Day 56
measure: Ocular surface redness
timeFrame: Day 56
measure: Lid margin redness/swelling
timeFrame: Day 56
measure: Cylindrical dandruff
timeFrame: Day 56
measure: Ocular surface staining
timeFrame: Day 56
measure: Physician's impression and patient impression
timeFrame: Day 56
measure: Tolerability of the wipes
timeFrame: Day 56
measure: Visual acuity
timeFrame: Day 56
measure: Assessment of ease of use
timeFrame: Day 56
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Consultation office
Study officials:
References: