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SALUKI: Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

Sponsor
University of Waterloo (Other)
Overall Status
Suspended
CT.gov ID
NCT04205162
Collaborator
Alcon Research (Industry)
60
Enrollment
1
Location
2
Arms
29.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist).

Condition or Disease Intervention/Treatment Phase
  • Device: Verafilcon A
  • Device: Etafilcon A
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Participants and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.
Primary Purpose:
Treatment
Official Title:
Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses
Actual Study Start Date :
Dec 13, 2019
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Verofilcon A / Etafilcon A

The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.

Device: Verafilcon A
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Names:
  • Precision1™

    • Device: Etafilcon A
    Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
    Other Names:
  • Acuvue® Moist

    		•
    Experimental: Etafilcon A / Verofilcon A

    The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.

    Device: Verafilcon A
    Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
    Other Names:
  • Precision1™

    • Device: Etafilcon A
    Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
    Other Names:
  • Acuvue® Moist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Subjective ratings of lens handling for insertion [Baseline]

      Participants rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best).

    2. Subjective ratings of lens handling for removal [Baseline]

      Participants rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Is between 18 and 40 years of age inclusively and has full legal capacity to volunteer;

    2. Has read and signed an information consent letter;

    3. Is willing and able to follow instructions and maintain the appointment schedule;

    4. Is a neophyte who has no history of any previous contact lens handling experience;

    5. Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);

    6. Has visual acuity ≤0.20 logMAR each eye with study lenses;

    7. Demonstrates acceptable fit with study lenses;

    8. Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye);

    9. Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the study

    Exclusion Criteria:

    1. Is participating in any concurrent clinical or research study;

    2. Has any known active* ocular disease and/or infection;

    3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

    4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

    5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

    6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);

    7. Is aphakic;

    8. Has undergone refractive error surgery;

    9. Has taken part in another clinical research study within the last 14 days;

    10. Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.

    • 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 are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Ocular Research & Education Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • University of Waterloo
    • Alcon Research

    Investigators

    • Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Waterloo
    ClinicalTrials.gov Identifier:
    NCT04205162
    Other Study ID Numbers:
    • 41693
    First Posted:
    Dec 19, 2019
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Feb 15, 2022