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

Dry Eye Clinical Trial

— SPANIEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987230
• Other study ID #: 40995
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: June 18, 2019

Study information

• Verified date: June 2019
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye

Intervention

Drug:
• Sensitive Eyes® Plus Saline Solution
Sensitive Eyes® Plus Saline Solution

Other:
• 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

Locations

Country	Name	City	State
Canada	Centre for Ocular Research & Education	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant's Subjective discomfort - Baseline	Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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