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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

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE May 29, 2019
Actual Primary Completion Date June 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Participant's Subjective discomfort - Baseline [ Time Frame: 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 [ Time Frame: Immediately 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: Between 0 and 600 seconds after application ]
    Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03987230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Official Title  ICMJE Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: Sensitive Eyes® Plus Saline Solution
    Sensitive Eyes® Plus Saline Solution
  • Other: Oust™ Demodex® Wipes™
    Oust™ Demodex® Wipes™
  • Other: I-LID N LASH PLUS® Eyelid Cleanser
    I-LID N LASH PLUS® Eyelid Cleanser
  • Other: Blephadex Lid Wipes
    Blephadex Lid Wipes
  • Other: Eye Cleanse Lid Wipes
    Eye Cleanse Lid Wipes
  • Other: Blephademodex
    Blephademodex
Study Arms  ICMJE
  • Active Comparator: Oust™ Demodex® Wipes™
    Participant cleans eyelids with Oust™ Demodex® Wipes™
    Intervention: Other: Oust™ Demodex® Wipes™
  • Active Comparator: I-LID N LASH PLUS® Eyelid Cleanser
    Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser
    Intervention: Other: I-LID N LASH PLUS® Eyelid Cleanser
  • Active Comparator: Blephadex Lid Wipes
    Participant cleans eyelids with Blephadex Lid Wipes
    Intervention: Other: Blephadex Lid Wipes
  • Active Comparator: Eye Cleanse Lid Wipes
    Participant cleans eyelids with Eye Cleanse Lid Wipes
    Intervention: Other: Eye Cleanse Lid Wipes
  • Active Comparator: Blephademodex
    Participant cleans eyelids with Blephademodex
    Intervention: Other: Blephademodex
  • Placebo Comparator: Sensitive Eyes® Plus Saline Solution
    Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution
    Intervention: Drug: Sensitive Eyes® Plus Saline Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
15
Actual Study Completion Date  ICMJE June 18, 2019
Actual Primary Completion Date June 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987230
Other Study ID Numbers  ICMJE 40995
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Waterloo
Study Sponsor  ICMJE University of Waterloo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Waterloo
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP