Presbyopia
Conditions
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.
Interventions
DEVICEsomofilcon A multifocal lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Clarity During the Day - Distance Vision | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline | Distance visual acuity (logMAR) |
| Post-blink Lens Movement | 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. |
| Corneal Staining | 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. |
| Conjunctival Staining | 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. |
| Bulbar Hyperemia | 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. |
| Subjective Vision Satisfaction - Driving at Night | 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) |
| Subjective Vision Satisfaction - Long Intermediate Vision | 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) |
| Number of Participants With Lens Centration | Baseline | Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm)) |
| Subjective Vision Satisfaction - Near Vision | 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) |
| Ease of Insertion | Baseline | 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 Removal | 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) |
| Overall Satisfaction With Speed of Changing Focus | 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) |
| Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Baseline | Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation) |
| Overall Comfort | 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) |
| Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | 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) |
| Subjective Vision Satisfaction - Short Intermediate Tasks | 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) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Screen Failure | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 7.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 41 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
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
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Met my expectations | 64.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 16.7 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 18.8 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Met my expectations | 70.8 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 12.5 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 16.7 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 18.8 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 16.7 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Met my expectations | 64.5 percentage of participants |
Primary
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Met my expectations | 68.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 22.9 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 8.3 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Met my expectations | 77.1 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 14.6 percentage of participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 8.3 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Fell short of my expectations | 27.1 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Exceeded my expectations | 4.2 percentage of participants |
| Habitual Lens - Distance Tasks in General | Vision Clarity During the Day - Distance Vision | Met my expectations | 68.7 percentage of participants |
Secondary
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Bulbar Hyperemia | Bulbar Hyperemia | 2.05 units on a scale | Standard Deviation 0.57 |
| Habitual Lens -Distance Vision While Driving During the Day | Bulbar Hyperemia | Limbal Hyperemia | 1.90 units on a scale | Standard Deviation 0.71 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Bulbar Hyperemia | Bulbar Hyperemia | 2.10 units on a scale | Standard Deviation 0.65 |
| Habitual Lens -Distance Vision While Driving During the Day | Bulbar Hyperemia | Limbal Hyperemia | 1.90 units on a scale | Standard Deviation 0.69 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Temporal | 10.31 units on a scale | Standard Deviation 12.3 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Superior | 7.70 units on a scale | Standard Deviation 12.8 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Nasal | 11.04 units on a scale | Standard Deviation 13 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Inferior | 9.69 units on a scale | Standard Deviation 13 |
Secondary
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Temporal | 16.87 units on a scale | Standard Deviation 22.2 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Superior | 7.60 units on a scale | Standard Deviation 15 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Nasal | 12.7 units on a scale | Standard Deviation 17.2 |
| Habitual Lens -Distance Vision While Driving During the Day | Conjunctival Staining | Inferior | 11.8 units on a scale | Standard Deviation 19.5 |
Secondary
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Temporal | 1.77 units on a scale | Standard Deviation 7.75 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Superior | 1.04 units on a scale | Standard Deviation 3.57 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Nasal | 1.15 units on a scale | Standard Deviation 4.03 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Inferior | 3.06 units on a scale | Standard Deviation 9.54 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Central | 0.75 units on a scale | Standard Deviation 3.57 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Temporal | 1.15 units on a scale | Standard Deviation 4.28 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Superior | 1.15 units on a scale | Standard Deviation 4.28 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Nasal | 1.35 units on a scale | Standard Deviation 5.03 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Inferior | 2.81 units on a scale | Standard Deviation 6.6 |
| Habitual Lens -Distance Vision While Driving During the Day | Corneal Staining | Central | 1.88 units on a scale | Standard Deviation 6.87 |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Fell short of expectations | 6.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Met expectations | 81.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Exceeded expectations | 12.4 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Fell short of expectations | 6.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Met expectations | 60.4 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Insertion | Exceeded expectations | 33.3 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Fell short of expectations | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Met expectations | 62.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Exceeded expectations | 22.9 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Fell short of expectations | 4.2 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Met expectations | 83.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Ease of Removal | Exceeded expectations | 12.5 percentage of participants |
Secondary
Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm))
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Optimum | 40 Participants |
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Acceptable decentration | 8 Participants |
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Unacceptable decentration | 0 Participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Number of Participants With Lens Centration | Optimum | 34 Participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Number of Participants With Lens Centration | Acceptable decentration | 14 Participants |
| Habitual Lens - Distance Tasks in Good Lighting. | Number of Participants With Lens Centration | Unacceptable decentration | 0 Participants |
Secondary
Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm))
Time frame: 3 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Optimum | 32 Participants |
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Acceptable decentration | 16 Participants |
| Habitual Lens -Distance Vision While Driving During the Day | Number of Participants With Lens Centration | Unacceptable decentration | 0 Participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Comfort | Prefer my own strongly | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Comfort | Prefer my own slightly | 10.4 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Comfort | No preference | 22.9 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Comfort | Prefer study lenses slightly | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Comfort | Prefer study lenses strongly | 37.5 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Prefer my own strongly | 14.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Prefer my own slightly | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | No Preference | 18.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Prefer study lenses slightly | 22.9 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Prefer study lenses strongly | 29.2 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Fell Short of expectations | 18.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Met expectations | 68.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Exceeded expectations | 12.4 percentage of participants |
Secondary
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))
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Fell Short of expectations | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Met expectations | 58.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Exceeded expectations | 27.1 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Fell short of expectations | 6.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Met expectations | 66.7 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Exceeded expectations | 27.0 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Fell short of expectations | 12.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Met expectations | 75.0 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Overall Satisfaction With Speed of Changing Focus | Exceeded expectations | 12.5 percentage of participants |
Secondary
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Insufficient | 0 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Minimal, but acceptable movement | 8.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Optimal Movement | 77.1 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Moderate, but acceptable Movement | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Excessive unacceptable | 0 percentage of participants |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Minimal, but acceptable movement | 20.8 percentage of particpants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Moderate, but acceptable Movement | 6.3 percentage of particpants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Optimal Movement | 72.9 percentage of particpants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Excessive unacceptable | 0 percentage of particpants |
| Habitual Lens -Distance Vision While Driving During the Day | Post-blink Lens Movement | Insufficient | 0 percentage of particpants |
| Habitual Lens - Distance Tasks in Good Lighting. | Post-blink Lens Movement | Excessive unacceptable | 0 percentage of particpants |
| Habitual Lens - Distance Tasks in Good Lighting. | Post-blink Lens Movement | Insufficient | 0 percentage of particpants |
| Habitual Lens - Distance Tasks in Good Lighting. | Post-blink Lens Movement | Minimal, but acceptable movement | 8.3 percentage of particpants |
| Habitual Lens - Distance Tasks in Good Lighting. | Post-blink Lens Movement | Optimal Movement | 70.8 percentage of particpants |
| Habitual Lens - Distance Tasks in Good Lighting. | Post-blink Lens Movement | Moderate, but acceptable Movement | 20.8 percentage of particpants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Fell short of expectations | 22.9 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Met expectations | 68.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Exceeded expectations | 8.3 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Fell short of expectations | 16.7 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Met expectations | 64.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Driving at Night | Exceeded expectations | 18.8 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Fell short of expectations | 12.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Met expectations | 85.4 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Exceeded expectation | 2.1 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Fell short of expectations | 8.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Met expectations | 66.7 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Long Intermediate Vision | Exceeded expectation | 25.0 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Fell short of expectations | 16.7 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Met expectations | 56.3 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Exceeded expectations | 27.0 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Fell short of expectations | 43.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Met expectations | 50.0 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Near Vision | Exceeded expectations | 6.2 percentage of participants |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Fell short of expectations | 22.9 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Met expectations | 70.8 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Exceeded expectations | 6.3 percentage of participants |
Secondary
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)
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Fell short of expectations | 14.6 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Met expectations | 62.5 percentage of participants |
| Habitual Lens -Distance Vision While Driving During the Day | Subjective Vision Satisfaction - Short Intermediate Tasks | Exceeded expectations | 22.9 percentage of participants |
Secondary
Visual Acuity
Distance visual acuity (logMAR)
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Visual Acuity | Right Eye | 0.00 logMar | Standard Deviation 0.09 |
| Habitual Lens -Distance Vision While Driving During the Day | Visual Acuity | Both Eyes | -0.04 logMar | Standard Deviation 0.09 |
Secondary
Visual Acuity
Distance visual acuity (logMAR)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens -Distance Vision While Driving During the Day | Visual Acuity | Right Eye | 0.10 logMar | Standard Deviation 0.12 |
| Habitual Lens -Distance Vision While Driving During the Day | Visual Acuity | Both Eyes | -0.01 logMar | Standard Deviation 0.09 |
| Habitual Lens - Distance Tasks in Good Lighting. | Visual Acuity | Right Eye | 0.02 logMar | Standard Deviation 0.11 |
| Habitual Lens - Distance Tasks in Good Lighting. | Visual Acuity | Both Eyes | -0.05 logMar | Standard Deviation 0.08 |