Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
NCT ID: NCT03987230
Last Updated: 2019-07-29
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
17 participants
INTERVENTIONAL
2019-05-29
2019-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Oust™ Demodex® Wipes™
Participant cleans eyelids with Oust™ Demodex® Wipes™
Oust™ Demodex® Wipes™
Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid Cleanser
Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser
I-LID N LASH PLUS® Eyelid Cleanser
I-LID N LASH PLUS® Eyelid Cleanser
Blephadex Lid Wipes
Participant cleans eyelids with Blephadex Lid Wipes
Blephadex Lid Wipes
Blephadex Lid Wipes
Eye Cleanse Lid Wipes
Participant cleans eyelids with Eye Cleanse Lid Wipes
Eye Cleanse Lid Wipes
Eye Cleanse Lid Wipes
Blephademodex
Participant cleans eyelids with Blephademodex
Blephademodex
Blephademodex
Sensitive Eyes® Plus Saline Solution
Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution
Sensitive Eyes® Plus Saline Solution
Sensitive Eyes® Plus Saline Solution
Interventions
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Sensitive Eyes® Plus Saline Solution
Sensitive Eyes® Plus Saline Solution
Oust™ Demodex® Wipes™
Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid Cleanser
I-LID N LASH PLUS® Eyelid Cleanser
Blephadex Lid Wipes
Blephadex Lid Wipes
Eye Cleanse Lid Wipes
Eye Cleanse Lid Wipes
Blephademodex
Blephademodex
Eligibility Criteria
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Inclusion Criteria
2. Has read and signed an informed consent letter;
3. Agrees to refrain from the use of ocular lubricants during the study period;
4. Agrees to not to use eye-related cosmetics for upcoming study visits
5. Is willing to use the study products
6. Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule;
7. Has corneal sensitivity within physiological limits.
Exclusion Criteria
2. Is a contact lens wearer (due to reduced corneal sensitivity);
3. Has any known active\* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
4. Has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable;
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study (such as fluorescein dye to highlight structures of the eye and used regularly in optometric practice) and study products in this study;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment; (due to the possibility of fluctuating vision as a consequence of variation in hormone levels);8
8. Has undergone refractive error surgery (e.g. LASIK, PRK);
9. Is a smoker (as smoking reduces tear film stability) \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye (Ocular Surface Disease Index, OSDI\<23/100) are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Waterloo
OTHER
Responsible Party
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Locations
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Centre for Ocular Research & Education
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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40995
Identifier Type: -
Identifier Source: org_study_id
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