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

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
somofilcon A multifocal lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Somofilcon A multifocal lens

Arm Description

Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.

Outcomes

Primary Outcome Measures

Vision Clarity During the Day - Distance Vision
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
Vision Clarity During the Day - Distance Vision
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 Outcome Measures

Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Visual Acuity
Distance visual acuity (logMAR)
Visual Acuity
Distance visual acuity (logMAR)
Post-blink Lens Movement
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.
Post-blink Lens Movement
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.
Corneal Staining
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.
Corneal Staining
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.
Conjunctival Staining
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.
Conjunctival Staining
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.
Bulbar Hyperemia
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.
Bulbar Hyperemia
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.
Subjective Vision Satisfaction - Driving at Night
Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)
Subjective Vision Satisfaction - Driving at Night
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)
Subjective Vision Satisfaction - Long Intermediate Vision
Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Subjective Vision Satisfaction - Long Intermediate Vision
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)
Subjective Vision Satisfaction - Short Intermediate Tasks
Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Subjective Vision Satisfaction - Short Intermediate Tasks
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)
Subjective Vision Satisfaction - Near Vision
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)
Subjective Vision Satisfaction - Near Vision
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)
Ease of Insertion
Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Ease of Insertion
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)
Ease of Removal
Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Ease of Removal
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)
Overall Satisfaction With Speed of Changing Focus
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)
Overall Satisfaction With Speed of Changing Focus
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)
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))
Overall Comfort
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)
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle
Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)

Full Information

First Posted
May 1, 2018
Last Updated
December 10, 2019
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03519919
Brief Title
Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study
Official Title
Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
September 22, 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somofilcon A multifocal lens
Arm Type
Experimental
Arm Description
Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.
Intervention Type
Device
Intervention Name(s)
somofilcon A multifocal lens
Other Intervention Name(s)
clarifi multifocal lens
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Vision Clarity During the Day - Distance Vision
Description
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
Time Frame
Baseline
Title
Vision Clarity During the Day - Distance Vision
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Lens Centration
Description
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Time Frame
Baseline
Title
Number of Participants With Lens Centration
Description
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Time Frame
3 weeks
Title
Visual Acuity
Description
Distance visual acuity (logMAR)
Time Frame
Baseline
Title
Visual Acuity
Description
Distance visual acuity (logMAR)
Time Frame
3 weeks
Title
Post-blink Lens Movement
Description
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.
Time Frame
Baseline
Title
Post-blink Lens Movement
Description
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.
Time Frame
3 weeks
Title
Corneal Staining
Description
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.
Time Frame
Baseline
Title
Corneal Staining
Description
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.
Time Frame
3 weeks
Title
Conjunctival Staining
Description
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.
Time Frame
Baseline
Title
Conjunctival Staining
Description
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.
Time Frame
3 weeks
Title
Bulbar Hyperemia
Description
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.
Time Frame
Baseline
Title
Bulbar Hyperemia
Description
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.
Time Frame
3 weeks
Title
Subjective Vision Satisfaction - Driving at Night
Description
Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)
Time Frame
Baseline
Title
Subjective Vision Satisfaction - Driving at Night
Description
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)
Time Frame
3 weeks
Title
Subjective Vision Satisfaction - Long Intermediate Vision
Description
Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Time Frame
Baseline
Title
Subjective Vision Satisfaction - Long Intermediate Vision
Description
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)
Time Frame
3 weeks
Title
Subjective Vision Satisfaction - Short Intermediate Tasks
Description
Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Time Frame
Baseline
Title
Subjective Vision Satisfaction - Short Intermediate Tasks
Description
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)
Time Frame
3 weeks
Title
Subjective Vision Satisfaction - Near Vision
Description
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)
Time Frame
Baseline
Title
Subjective Vision Satisfaction - Near Vision
Description
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)
Time Frame
3 weeks
Title
Ease of Insertion
Description
Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Time Frame
Baseline
Title
Ease of Insertion
Description
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)
Time Frame
3 weeks
Title
Ease of Removal
Description
Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Time Frame
Baseline
Title
Ease of Removal
Description
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)
Time Frame
3 weeks
Title
Overall Satisfaction With Speed of Changing Focus
Description
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)
Time Frame
Baseline
Title
Overall Satisfaction With Speed of Changing Focus
Description
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)
Time Frame
3 weeks
Title
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Description
Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)
Time Frame
Baseline
Title
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Description
Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))
Time Frame
3 weeks
Title
Overall Comfort
Description
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)
Time Frame
3 weeks
Title
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle
Description
Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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

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