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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oust™ Demodex® Wipes™; Participant cleans eyelids with Oust™ Demodex® Wipes™	Other: Oust™ Demodex® Wipes™; Oust™ Demodex® Wipes™
Active Comparator: I-LID N LASH PLUS® Eyelid Cleanser; Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser	Other: I-LID N LASH PLUS® Eyelid Cleanser; I-LID N LASH PLUS® Eyelid Cleanser
Active Comparator: Blephadex Lid Wipes; Participant cleans eyelids with Blephadex Lid Wipes	Other: Blephadex Lid Wipes; Blephadex Lid Wipes
Active Comparator: Eye Cleanse Lid Wipes; Participant cleans eyelids with Eye Cleanse Lid Wipes	Other: Eye Cleanse Lid Wipes; Eye Cleanse Lid Wipes
Active Comparator: Blephademodex; Participant cleans eyelids with Blephademodex	Other: Blephademodex; Blephademodex
Placebo Comparator: Sensitive Eyes® Plus Saline Solution; Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution	Drug: Sensitive Eyes® Plus Saline Solution; Sensitive Eyes® Plus Saline Solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 40995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No