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

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sensitive Eyes® Plus Saline Solution
Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid Cleanser
Blephadex Lid Wipes
Eye Cleanse Lid Wipes
Blephademodex
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Ocular Research & Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes

Eye Cleanse Lid Wipes

Blephademodex

Sensitive Eyes® Plus Saline Solution

Arm Description

Participant cleans eyelids with Oust™ Demodex® Wipes™

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

Participant cleans eyelids with Blephadex Lid Wipes

Participant cleans eyelids with Eye Cleanse Lid Wipes

Participant cleans eyelids with Blephademodex

Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Outcomes

Primary Outcome Measures

Participant's Subjective discomfort - Baseline
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 0 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 45 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 75 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 195 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 225 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 255 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 285 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 330 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 450 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 510 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
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 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
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
Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds

Secondary Outcome Measures

Full Information

First Posted
June 5, 2019
Last Updated
July 26, 2019
Sponsor
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT03987230
Brief Title
Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Acronym
SPANIEL
Official Title
Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant receives 6 different interventions in random order
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oust™ Demodex® Wipes™
Arm Type
Active Comparator
Arm Description
Participant cleans eyelids with Oust™ Demodex® Wipes™
Arm Title
I-LID N LASH PLUS® Eyelid Cleanser
Arm Type
Active Comparator
Arm Description
Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser
Arm Title
Blephadex Lid Wipes
Arm Type
Active Comparator
Arm Description
Participant cleans eyelids with Blephadex Lid Wipes
Arm Title
Eye Cleanse Lid Wipes
Arm Type
Active Comparator
Arm Description
Participant cleans eyelids with Eye Cleanse Lid Wipes
Arm Title
Blephademodex
Arm Type
Active Comparator
Arm Description
Participant cleans eyelids with Blephademodex
Arm Title
Sensitive Eyes® Plus Saline Solution
Arm Type
Placebo Comparator
Arm Description
Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution
Intervention Type
Drug
Intervention Name(s)
Sensitive Eyes® Plus Saline Solution
Intervention Description
Sensitive Eyes® Plus Saline Solution
Intervention Type
Other
Intervention Name(s)
Oust™ Demodex® Wipes™
Intervention Description
Oust™ Demodex® Wipes™
Intervention Type
Other
Intervention Name(s)
I-LID N LASH PLUS® Eyelid Cleanser
Intervention Description
I-LID N LASH PLUS® Eyelid Cleanser
Intervention Type
Other
Intervention Name(s)
Blephadex Lid Wipes
Intervention Description
Blephadex Lid Wipes
Intervention Type
Other
Intervention Name(s)
Eye Cleanse Lid Wipes
Intervention Description
Eye Cleanse Lid Wipes
Intervention Type
Other
Intervention Name(s)
Blephademodex
Intervention Description
Blephademodex
Primary Outcome Measure Information:
Title
Participant's Subjective discomfort - Baseline
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
Baseline
Title
Participant's Subjective discomfort - 0 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
Immediately after application
Title
Participant's Subjective discomfort - 15 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
15 seconds after application
Title
Participant's Subjective discomfort - 30 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
30 seconds after application
Title
Participant's Subjective discomfort - 45 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
45 seconds after application
Title
Participant's Subjective discomfort - 60 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
60 seconds after application
Title
Participant's Subjective discomfort - 75 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
75 seconds after application
Title
Participant's Subjective discomfort - 90 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
90 seconds after application
Title
Participant's Subjective discomfort - 105 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
105 seconds after application
Title
Participant's Subjective discomfort - 120 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
120 seconds after application
Title
Participant's Subjective discomfort - 135 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
135 seconds after application
Title
Participant's Subjective discomfort - 150 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
150 seconds after application
Title
Participant's Subjective discomfort - 165 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
165 seconds after application
Title
Participant's Subjective discomfort - 180 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
180 seconds after application
Title
Participant's Subjective discomfort - 195 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
195 seconds after application
Title
Participant's Subjective discomfort - 210 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
210 seconds after application
Title
Participant's Subjective discomfort - 225 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
225 seconds after application
Title
Participant's Subjective discomfort - 240 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
240 seconds after application
Title
Participant's Subjective discomfort - 255 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
255 seconds after application
Title
Participant's Subjective discomfort - 270 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
270 seconds after application
Title
Participant's Subjective discomfort - 285 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
285 seconds after application
Title
Participant's Subjective discomfort - 300 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
300 seconds after application
Title
Participant's Subjective discomfort - 330 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
330 seconds after application
Title
Participant's Subjective discomfort - 360 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
360 seconds after application
Title
Participant's Subjective discomfort - 390 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
390 seconds after application
Title
Participant's Subjective discomfort - 420 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
420 seconds after application
Title
Participant's Subjective discomfort - 450 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
450 seconds after application
Title
Participant's Subjective discomfort - 480 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
480 seconds after application
Title
Participant's Subjective discomfort - 510 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
510 seconds after application
Title
Participant's Subjective discomfort - 540 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
540 seconds after application
Title
Participant's Subjective discomfort - 570 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
570 seconds after application
Title
Participant's Subjective discomfort - 600 seconds after application
Description
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time Frame
600 seconds after application
Title
Time to comfortably open the eyes after the application of eyelid cleansing wipe
Description
Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds
Time Frame
Between 0 and 600 seconds after application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Centre for Ocular Research & Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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