Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-09-11
2020-05-14
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm
Blephademodex
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.
Interventions
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Blephademodex
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Locations
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Consultation office
Heidelberg, , Germany
Countries
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Other Identifiers
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LTPIVBDX19
Identifier Type: -
Identifier Source: org_study_id
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