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

NCT03987230 | Completed

• 1 other identifier: 40995
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (33)

• 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

Study Arms (6)

Oust™ Demodex® Wipes™

ACTIVE COMPARATOR

Participant cleans eyelids with Oust™ Demodex® Wipes™

Other: Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser

ACTIVE COMPARATOR

Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser

Other: I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes

ACTIVE COMPARATOR

Participant cleans eyelids with Blephadex Lid Wipes

Other: Blephadex Lid Wipes

Eye Cleanse Lid Wipes

ACTIVE COMPARATOR

Participant cleans eyelids with Eye Cleanse Lid Wipes

Other: Eye Cleanse Lid Wipes

Blephademodex

ACTIVE COMPARATOR

Participant cleans eyelids with Blephademodex

Other: Blephademodex

Sensitive Eyes® Plus Saline Solution

PLACEBO COMPARATOR

Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Drug: Sensitive Eyes® Plus Saline Solution

Interventions

Sensitive Eyes® Plus Saline Solution DRUG

Sensitive Eyes® Plus Saline Solution

Sensitive Eyes® Plus Saline Solution

Oust™ Demodex® Wipes™ OTHER

Oust™ Demodex® Wipes™

Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser OTHER

I-LID N LASH PLUS® Eyelid Cleanser

I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes OTHER

Blephadex Lid Wipes

Blephadex Lid Wipes

Eye Cleanse Lid Wipes OTHER

Eye Cleanse Lid Wipes

Eye Cleanse Lid Wipes

Blephademodex OTHER

Blephademodex

Blephademodex

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
• Has read and signed an informed consent letter;
• Agrees to refrain from the use of ocular lubricants during the study period;
• Agrees to not to use eye-related cosmetics for upcoming study visits
• Is willing to use the study products
• Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule;
• Has corneal sensitivity within physiological limits.

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Is a contact lens wearer (due to reduced corneal sensitivity);
• Has any known active\* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
• 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;
• 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;
• 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;
• 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
• Has undergone refractive error surgery (e.g. LASIK, PRK);
• 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.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant receives 6 different interventions in random order

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 14, 2019
• Study Start: May 29, 2019
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)