Efficacy and Tolerability of Blephademodex Wipes

Thea Pharma

Status

Completed

Conditions

Demodex Blepharitis

Treatments

Device: Blephademodex

Study type

Interventional

Funder types

Industry

Identifiers

LTPIVBDX19

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

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