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Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

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ClinicalTrials.gov Identifier: NCT03519919
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.

Condition or disease Intervention/treatment Phase
Presbyopia Device: somofilcon A multifocal lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : September 22, 2018
Actual Study Completion Date : February 15, 2019

Arm Intervention/treatment
Experimental: Somofilcon A multifocal lens
Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.
Device: somofilcon A multifocal lens
contact lens
Other Name: clarifi multifocal lens




Primary Outcome Measures :
  1. Daytime vision clarity [ Time Frame: 3 weeks ]
    Vision clarity during the day (distance)


Secondary Outcome Measures :
  1. Vision satisfaction - driving at night [ Time Frame: 3 weeks ]
    Satisfaction of distance vision while driving (fell short of expectation, met expectation, exceed expectation)

  2. Vision satisfaction - TV viewing [ Time Frame: 3 weeks ]
    Satisfaction of distance vision while viewing TV (fell short of expectation, met expectation, exceed expectation)

  3. Vision satisfaction - Desktop computer [ Time Frame: 3 weeks ]
    Satisfaction of intermediate vision while using desktop computer (fell short of expectation, met expectation, exceed expectation)

  4. Vision satisfaction - Laptop/tablet [ Time Frame: 3 weeks ]
    Satisfaction of short/intermediate vision while using laptop/tablet (fell short of expectation, met expectation, exceed expectation)

  5. Vision satisfaction - Reading on cell phone [ Time Frame: 3 weeks ]
    Satisfaction of near vision while reading on cell phone (fell short of expectation, met expectation, exceed expectation)

  6. Vision satisfaction - Reading printed material [ Time Frame: 3 weeks ]
    Satisfaction of near vision while reading hand-held printed materials (fell short of expectation, met expectation, exceed expectation)

  7. Overall Comfort [ Time Frame: 3 weeks ]
    Subjective rating of comfort (fell short of expectation, met expectation, exceed expectation)

  8. Visual Acuity [ Time Frame: 3 weeks ]
    Distance visual acuity (logMAR)

  9. Lens centration [ Time Frame: 3 weeks ]
    Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))

  10. Lens Mobility [ Time Frame: 3 weeks ]
    Movement of lens on eye after blink (Scale 0-4: 0=Insufficient, 2=Optimal, 4=Excessive)

  11. Bulbar redness [ Time Frame: 3 weeks ]
    Grading redness of bulbar conjunctiva (Scale 0-4: 0=None, 4=Severe)

  12. Corneal Staining Superior [ Time Frame: 3 weeks ]
    Corneal staining in superior region

  13. Corneal Staining Temporal [ Time Frame: 3 weeks ]
    Corneal staining in temporal region

  14. Corneal Staining Nasal [ Time Frame: 3 weeks ]
    Corneal staining in nasal region

  15. Corneal Staining Inferior [ Time Frame: 3 weeks ]
    Corneal staining in inferior region

  16. Corneal Staining Central [ Time Frame: 3 weeks ]
    Corneal staining in central region

  17. Conjunctival Staining Central [ Time Frame: 3 weeks ]
    Conjunctival staining in central region

  18. Conjunctival Staining Superior [ Time Frame: 3 weeks ]
    Conjunctival staining in superior region

  19. Conjunctival Staining Temporal [ Time Frame: 3 weeks ]
    Conjunctival staining in temporal region

  20. Conjunctival Staining Nasal [ Time Frame: 3 weeks ]
    Conjunctival staining in nasal region

  21. Conjunctival Staining Inferior [ Time Frame: 3 weeks ]
    Conjunctival staining in inferior region

  22. Ease of insertion [ Time Frame: 3 weeks ]
    Rating how easy lens was inserted on eye (Fell short of expectation, Met expectation, Exceeded expectations)

  23. Ease of Removal [ Time Frame: 3 weeks ]
    Rating how easy lens was removed from eye (Fell short of expectation, Met expectation, Exceeded expectations)

  24. Satisfaction of visual demand [ Time Frame: 3 weeks ]
    Vision clarity rating for all visual needs (Fell short of expectation, Met expectation, Exceeded expectations)

  25. Satisfaction with speed of changing focus [ Time Frame: 3 weeks ]
    Rating for speed and ability to change focus between distances (Fell short of expectation, Met expectation, Exceeded expectations)

  26. Overall preference between study and habitual contact lenses [ Time Frame: 3 weeks ]
    Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference)

  27. Preference between study and habitual contact lenses for lifestyle [ Time Frame: 3 weeks ]
    Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference)



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Has had a self-reported oculo-visual examination in the last two years.
  • Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
  • Presently wears lenses for minimum wear 4 days/week and 10 hours/day
  • Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
  • Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
  • Current refraction indicates a reading addition of +1.50 or higher
  • Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
  • Spends 10 hrs or more indoors at least 5 days/week
  • Possesses a smartphone and is willing to download the MetricWire app to receive

Exclusion Criteria:

  • Is presently wearing Clariti 1 day multifocal lenses
  • Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
  • Is participating in any concurrent clinical or research study;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to fluorescein dye or products to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Is aphakic;
  • Has undergone refractive error surgery;
  • Is an employee of the Centre for Contact Lens Research

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): NCT03519919


Locations
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Canada, Ontario
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03519919     History of Changes
Other Study ID Numbers: EX-MKTG-81
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases