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

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ClinicalTrials.gov Identifier: NCT03987230
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Sensitive Eyes® Plus Saline Solution Other: Oust™ Demodex® Wipes™ Other: I-LID N LASH PLUS® Eyelid Cleanser Other: Blephadex Lid Wipes Other: Eye Cleanse Lid Wipes Other: Blephademodex Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each participant receives 6 different interventions in random order
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

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




Primary Outcome Measures :
  1. Participant's Subjective discomfort - Baseline [ Time Frame: Baseline ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  2. Participant's Subjective discomfort - 0 seconds after application [ Time Frame: Immediately after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  3. Participant's Subjective discomfort - 15 seconds after application [ Time Frame: 15 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  4. Participant's Subjective discomfort - 30 seconds after application [ Time Frame: 30 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  5. Participant's Subjective discomfort - 45 seconds after application [ Time Frame: 45 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  6. Participant's Subjective discomfort - 60 seconds after application [ Time Frame: 60 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  7. Participant's Subjective discomfort - 75 seconds after application [ Time Frame: 75 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  8. Participant's Subjective discomfort - 90 seconds after application [ Time Frame: 90 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  9. Participant's Subjective discomfort - 105 seconds after application [ Time Frame: 105 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  10. Participant's Subjective discomfort - 120 seconds after application [ Time Frame: 120 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  11. Participant's Subjective discomfort - 135 seconds after application [ Time Frame: 135 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  12. Participant's Subjective discomfort - 150 seconds after application [ Time Frame: 150 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  13. Participant's Subjective discomfort - 165 seconds after application [ Time Frame: 165 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  14. Participant's Subjective discomfort - 180 seconds after application [ Time Frame: 180 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  15. Participant's Subjective discomfort - 195 seconds after application [ Time Frame: 195 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  16. Participant's Subjective discomfort - 210 seconds after application [ Time Frame: 210 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  17. Participant's Subjective discomfort - 225 seconds after application [ Time Frame: 225 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  18. Participant's Subjective discomfort - 240 seconds after application [ Time Frame: 240 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  19. Participant's Subjective discomfort - 255 seconds after application [ Time Frame: 255 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  20. Participant's Subjective discomfort - 270 seconds after application [ Time Frame: 270 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  21. Participant's Subjective discomfort - 285 seconds after application [ Time Frame: 285 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  22. Participant's Subjective discomfort - 300 seconds after application [ Time Frame: 300 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  23. Participant's Subjective discomfort - 330 seconds after application [ Time Frame: 330 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  24. Participant's Subjective discomfort - 360 seconds after application [ Time Frame: 360 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  25. Participant's Subjective discomfort - 390 seconds after application [ Time Frame: 390 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  26. Participant's Subjective discomfort - 420 seconds after application [ Time Frame: 420 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  27. Participant's Subjective discomfort - 450 seconds after application [ Time Frame: 450 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  28. Participant's Subjective discomfort - 480 seconds after application [ Time Frame: 480 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  29. Participant's Subjective discomfort - 510 seconds after application [ Time Frame: 510 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  30. Participant's Subjective discomfort - 540 seconds after application [ Time Frame: 540 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  31. Participant's Subjective discomfort - 570 seconds after application [ Time Frame: 570 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  32. Participant's Subjective discomfort - 600 seconds after application [ Time Frame: 600 seconds after application ]
    Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)

  33. Time to comfortably open the eyes after the application of eyelid cleansing wipe [ Time Frame: Between 0 and 600 seconds after application ]
    Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987230


Locations
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Canada, Ontario
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo

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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT03987230     History of Changes
Other Study ID Numbers: 40995
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pharmaceutical Solutions