Clinical trial NCT03987230: Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Official title: Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant receives 6 different interventions in random order
Primary purpose: TREATMENT

Brief summary: This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum.


Eligibility criteria: Inclusion Criteria:

1. Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
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:

1. Is participating in any concurrent clinical or research study;
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.

Primary outcomes:
measure: Participant's Subjective discomfort - Baseline
timeFrame: Baseline
measure: Participant's Subjective discomfort - 0 seconds after application
timeFrame: Immediately after application
measure: Participant's Subjective discomfort - 15 seconds after application
timeFrame: 15 seconds after application
measure: Participant's Subjective discomfort - 30 seconds after application
timeFrame: 30 seconds after application
measure: Participant's Subjective discomfort - 45 seconds after application
timeFrame: 45 seconds after application
measure: Participant's Subjective discomfort - 60 seconds after application
timeFrame: 60 seconds after application
measure: Participant's Subjective discomfort - 75 seconds after application
timeFrame: 75 seconds after application
measure: Participant's Subjective discomfort - 90 seconds after application
timeFrame: 90 seconds after application
measure: Participant's Subjective discomfort - 105 seconds after application
timeFrame: 105 seconds after application
measure: Participant's Subjective discomfort - 120 seconds after application
timeFrame: 120 seconds after application
measure: Participant's Subjective discomfort - 135 seconds after application
timeFrame: 135 seconds after application
measure: Participant's Subjective discomfort - 150 seconds after application
timeFrame: 150 seconds after application
measure: Participant's Subjective discomfort - 165 seconds after application
timeFrame: 165 seconds after application
measure: Participant's Subjective discomfort - 180 seconds after application
timeFrame: 180 seconds after application
measure: Participant's Subjective discomfort - 195 seconds after application
timeFrame: 195 seconds after application
measure: Participant's Subjective discomfort - 210 seconds after application
timeFrame: 210 seconds after application
measure: Participant's Subjective discomfort - 225 seconds after application
timeFrame: 225 seconds after application
measure: Participant's Subjective discomfort - 240 seconds after application
timeFrame: 240 seconds after application
measure: Participant's Subjective discomfort - 255 seconds after application
timeFrame: 255 seconds after application
measure: Participant's Subjective discomfort - 270 seconds after application
timeFrame: 270 seconds after application
measure: Participant's Subjective discomfort - 285 seconds after application
timeFrame: 285 seconds after application
measure: Participant's Subjective discomfort - 300 seconds after application
timeFrame: 300 seconds after application
measure: Participant's Subjective discomfort - 330 seconds after application
timeFrame: 330 seconds after application
measure: Participant's Subjective discomfort - 360 seconds after application
timeFrame: 360 seconds after application
measure: Participant's Subjective discomfort - 390 seconds after application
timeFrame: 390 seconds after application
measure: Participant's Subjective discomfort - 420 seconds after application
timeFrame: 420 seconds after application
measure: Participant's Subjective discomfort - 450 seconds after application
timeFrame: 450 seconds after application
measure: Participant's Subjective discomfort - 480 seconds after application
timeFrame: 480 seconds after application
measure: Participant's Subjective discomfort - 510 seconds after application
timeFrame: 510 seconds after application
measure: Participant's Subjective discomfort - 540 seconds after application
timeFrame: 540 seconds after application
measure: Participant's Subjective discomfort - 570 seconds after application
timeFrame: 570 seconds after application
measure: Participant's Subjective discomfort - 600 seconds after application
timeFrame: 600 seconds after application
measure: Time to comfortably open the eyes after the application of eyelid cleansing wipe
timeFrame: Between 0 and 600 seconds after application
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
References: