Efficacy and Tolerability of Blephademodex Wipes

NCT04780165 | Completed

• 1 other identifier: LTPIVBDX19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Demodex Blepharitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Specific Blepharitis symptoms

  Day 56

• adapted Total Ocular Symptom Score (TOSS)

  Day 56

• Symptom Assessment in Dry Eye (SANDE)

  Day 56

• Demodex count

  Day 56

• Ocular surface redness

  Day 56

Study Arms (1)

Single-arm

EXPERIMENTAL

Device: Blephademodex

Interventions

Blephademodex DEVICE

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.

Also known as: Blephaclean

Single-arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Consultation office

Heidelberg, 69121, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: March 3, 2021
• Study Start: September 11, 2019
• Primary Completion: March 13, 2020
• Study Completion: May 14, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)