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Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users (PUG)

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ClinicalTrials.gov Identifier: NCT04201639
Recruitment Status : Suspended (COVID-19)
First Posted : December 17, 2019
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
University of Waterloo

Brief Summary:
The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

Condition or disease Intervention/treatment Phase
Myopia Device: Verofilcon A contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Refit
Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.
Device: Verofilcon A contact lenses
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Name: Precision1™




Primary Outcome Measures :
  1. Subjective comfort after contact lens insertion [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  2. Subjective dryness after contact lens insertion [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

  3. Subjective rating of clarity of vision after contact lens insertion [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

  4. Subjective comfort after contact lens insertion [ Time Frame: Day 1 ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  5. Subjective dryness after contact lens insertion [ Time Frame: Day 1 ]
    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

  6. Subjective rating of clarity of vision after contact lens insertion [ Time Frame: Day 1 ]
    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

  7. Subjective comfort after contact lens insertion [ Time Frame: Day 7 ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  8. Subjective dryness after contact lens insertion [ Time Frame: Day 7 ]
    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

  9. Subjective rating of clarity of vision after contact lens insertion [ Time Frame: Day 7 ]
    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

  10. Subjective comfort after contact lens insertion [ Time Frame: Day 10 ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  11. Subjective dryness after contact lens insertion [ Time Frame: Day 10 ]
    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

  12. Subjective rating of clarity of vision after contact lens insertion [ Time Frame: Day 10 ]
    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

  13. Subjective comfort after contact lens insertion [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  14. Subjective dryness after contact lens insertion [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  15. Subjective rating of clarity of vision after contact lens insertion [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

  16. Subjective comfort with contact lens wear after 6 hours of digital device use [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  17. Subjective dryness with contact lens wear after 6 hours of digital device use [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  18. Subjective rating of vision clarity with contact lens wear after 6 hours of digital device use [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  19. Subjective comfort with contact lens wear after 6 hours of digital device use [ Time Frame: Day 1 ]
    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  20. Subjective dryness with contact lens wear after 6 hours of digital device use [ Time Frame: Day 1 ]
    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  21. Subjective rating of vision clarity with contact lens wear after 6 hours of digital device use [ Time Frame: Day 1 ]
    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  22. Subjective comfort with contact lens wear after 6 hours of digital device use [ Time Frame: Day 7 ]
    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  23. Subjective dryness with contact lens wear after 6 hours of digital device use [ Time Frame: Day 7 ]
    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  24. Subjective rating of vision clarity with contact lens wear after 6 hours of digital device use [ Time Frame: Day 7 ]
    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  25. Subjective comfort with contact lens wear after 6 hours of digital device use [ Time Frame: Day 10 ]
    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  26. Subjective dryness with contact lens wear after 6 hours of digital device use [ Time Frame: Day 10 ]
    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  27. Subjective rating of vision clarity with contact lens wear after 6 hours of digital device use [ Time Frame: Day 10 ]
    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  28. Subjective comfort with contact lens wear after 6 hours of digital device use [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  29. Subjective dryness with contact lens wear after 6 hours of digital device use [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  30. Subjective rating of vision clarity with contact lens wear after 6 hours of digital device use [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

  31. Subjective Comfort at End of Day with contact lens wear [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  32. Subjective dryness at End of Day with contact lens wear [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  33. Subjective rating of vision clarity at End of Day with contact lens wear [ Time Frame: Dispense Visit (Day 0) ]
    Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

  34. Subjective Comfort at End of Day with contact lens wear [ Time Frame: Day 1 ]
    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  35. Subjective dryness at End of Day with contact lens wear [ Time Frame: Day 1 ]
    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  36. Subjective rating of vision clarity at End of Day with contact lens wear [ Time Frame: Day 1 ]
    Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

  37. Subjective Comfort at End of Day with contact lens wear [ Time Frame: Day 7 ]
    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  38. Subjective dryness at End of Day with contact lens wear [ Time Frame: Day 7 ]
    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  39. Subjective rating of vision clarity at End of Day with contact lens wear [ Time Frame: Day 7 ]
    Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).

  40. Subjective Comfort at End of Day with contact lens wear [ Time Frame: Day 10 ]
    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  41. Subjective dryness at End of Day with contact lens wear [ Time Frame: Day 10 ]
    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  42. Subjective rating of vision clarity at End of Day with contact lens wear [ Time Frame: Day 10 ]
    Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

  43. Subjective Comfort at End of Day with contact lens wear [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  44. Subjective dryness at End of Day with contact lens wear [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  45. Subjective rating of vision clarity at End of Day with contact lens wear [ Time Frame: Followup visit (Day 12-16) ]
    Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Is between 18 and 40 years of age (inclusive) 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 heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
  5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
  6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
  7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
  8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
  9. Is willing to wear Precision1 CLs at least 5 days per week and 10 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;
  7. Is aphakic;
  8. Has undergone refractive error surgery;

    • 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.

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): NCT04201639


Locations
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Canada, Ontario
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
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Principal Investigator: Lyndon Jones, PhD, FCOptom Centre for Ocular Research & Education
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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT04201639    
Other Study ID Numbers: 41694
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases