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.

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