Status:
COMPLETED
Efficacy and Tolerability of Blephademodex Wipes
Lead Sponsor:
Laboratoires Thea
Conditions:
Demodex Blepharitis
Eligibility:
All Genders
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04780165
Start Date
September 11 2019
End Date
May 14 2020
Last Update
March 3 2021
Active Locations (1)
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1
Consultation office
Heidelberg, Germany, 69121