Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Eye Cleanse Lid Wipes; Other: Blephademodex; Other: Blephadex Lid Wipes; Other: Oust™ Demodex® Wipes™; Other: I-LID N LASH PLUS® Eyelid Cleanser; Drug: Sensitive Eyes® Plus Saline Solution

• Registration Number: NCT03987230
• Lead Sponsor: University of Waterloo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-14
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eye Cleanse Lid Wipes	Eye Cleanse Lid Wipes	Participant cleans eyelids with Eye Cleanse Lid Wipes
Blephademodex	Blephademodex	Participant cleans eyelids with Blephademodex
Blephadex Lid Wipes	Blephadex Lid Wipes	Participant cleans eyelids with Blephadex Lid Wipes
Oust™ Demodex® Wipes™	Oust™ Demodex® Wipes™	Participant cleans eyelids with Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid Cleanser	I-LID N LASH PLUS® Eyelid Cleanser	Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser
Sensitive Eyes® Plus Saline Solution	Sensitive Eyes® Plus Saline Solution	Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Primary Outcome Measures

Name	Time	Method
Participant's Subjective discomfort - 75 seconds after application	75 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 165 seconds after application	165 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 180 seconds after application	180 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 195 seconds after application	195 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 225 seconds after application	225 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 45 seconds after application	45 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 90 seconds after application	90 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 105 seconds after application	105 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 120 seconds after application	120 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 255 seconds after application	255 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 285 seconds after application	285 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 510 seconds after application	510 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time to comfortably open the eyes after the application of eyelid cleansing wipe	Between 0 and 600 seconds after application	Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds
Participant's Subjective discomfort - 0 seconds after application	Immediately after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 135 seconds after application	135 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 150 seconds after application	150 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 330 seconds after application	330 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 390 seconds after application	390 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 420 seconds after application	420 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - Baseline	Baseline	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 15 seconds after application	15 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 30 seconds after application	30 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 60 seconds after application	60 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 450 seconds after application	450 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 540 seconds after application	540 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 210 seconds after application	210 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 270 seconds after application	270 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 300 seconds after application	300 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 360 seconds after application	360 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 480 seconds after application	480 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 570 seconds after application	570 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 600 seconds after application	600 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 240 seconds after application	240 seconds after application	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

Trial Locations

Locations (1)

Centre for Ocular Research & Education; 🇨🇦 Waterloo, Ontario, Canada