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Completed

NCT Number: NCT03519919

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

somofilcon A multifocal lens

Device

contact lens

Other names: clarifi multifocal lens

Primary outcomes

  1. Vision Clarity During the Day - Distance Vision

    Time frame: Baseline

    Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:

    Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3

  2. Vision Clarity During the Day - Distance Vision

    Time frame: 3 weeks

    Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:

    Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3

Secondary outcomes

  1. Number of Participants With Lens Centration

    Time frame: Baseline

    Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))

  2. Number of Participants With Lens Centration

    Time frame: 3 weeks

    Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))

  3. Visual Acuity

    Time frame: Baseline

    Distance visual acuity (logMAR)

  4. Visual Acuity

    Time frame: 3 weeks

    Distance visual acuity (logMAR)

  5. Post-blink Lens Movement

    Time frame: Baseline

    Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement.

  6. Post-blink Lens Movement

    Time frame: 3 weeks

    Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable.

  7. Corneal Staining

    Time frame: Baseline

    Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.

  8. Corneal Staining

    Time frame: 3 weeks

    Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.

  9. Conjunctival Staining

    Time frame: Baseline

    Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior.

  10. Conjunctival Staining

    Time frame: 3 weeks

    Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior.

  11. Bulbar Hyperemia

    Time frame: Baseline

    Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.

  12. Bulbar Hyperemia

    Time frame: 3 weeks

    Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.

  13. Subjective Vision Satisfaction - Driving at Night

    Time frame: Baseline

    Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)

  14. Subjective Vision Satisfaction - Driving at Night

    Time frame: 3 weeks

    Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)

  15. Subjective Vision Satisfaction - Long Intermediate Vision

    Time frame: Baseline

    Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)

  16. Subjective Vision Satisfaction - Long Intermediate Vision

    Time frame: 3 weeks

    Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)

  17. Subjective Vision Satisfaction - Short Intermediate Tasks

    Time frame: Baseline

    Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)

  18. Subjective Vision Satisfaction - Short Intermediate Tasks

    Time frame: 3 weeks

    Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)

  19. Subjective Vision Satisfaction - Near Vision

    Time frame: Baseline

    Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)

  20. Subjective Vision Satisfaction - Near Vision

    Time frame: 3 weeks

    Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)

  21. Ease of Insertion

    Time frame: Baseline

    Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  22. Ease of Insertion

    Time frame: 3 weeks

    Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  23. Ease of Removal

    Time frame: Baseline

    Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  24. Ease of Removal

    Time frame: 3 weeks

    Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  25. Overall Satisfaction With Speed of Changing Focus

    Time frame: Baseline

    Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  26. Overall Satisfaction With Speed of Changing Focus

    Time frame: 3 weeks

    Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)

  27. Overall Satisfaction Preference Between Study and Habitual Contact Lenses

    Time frame: Baseline

    Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)

  28. Overall Satisfaction Preference Between Study and Habitual Contact Lenses

    Time frame: 3 weeks

    Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))

  29. Overall Comfort

    Time frame: 3 weeks

    Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)

  30. Overall 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, Prefer study lenses slightly, Prefer study lenses strongly)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 9, 2018
Registry last updated
Dec 19, 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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