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OpenTrials
Completed

NCT Number: NCT03987230

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensitive Eyes® Plus Saline Solution

Drug

Sensitive Eyes® Plus Saline Solution

Oust™ Demodex® Wipes™

Other

Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser

Other

I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes

Other

Blephadex Lid Wipes

Eye Cleanse Lid Wipes

Other

Eye Cleanse Lid Wipes

Blephademodex

Other

Blephademodex

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Acronym: SPANIEL

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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