Trial Outcomes & Findings for Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study (NCT NCT03519919)

NCT ID: NCT03519919

Last Updated: 2019-12-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-12-19

Participant Flow

Participant milestones

Measure	Somofilcon A Multifocal Lens Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. somofilcon A multifocal lens: contact lens
Overall Study STARTED	51
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Somofilcon A Multifocal Lens Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. somofilcon A multifocal lens: contact lens
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1
Overall Study Screen Failure	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=51 Participants Total Participants
Age, Continuous	55.6 years STANDARD_DEVIATION 7.3 • n=51 Participants
Sex: Female, Male Female	41 Participants n=51 Participants
Sex: Female, Male Male	10 Participants n=51 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Vision Clarity During the Day - Distance Vision Fell short of my expectations	22.9 percentage of participants	14.6 percentage of participants	27.1 percentage of participants
Vision Clarity During the Day - Distance Vision Met my expectations	68.8 percentage of participants	77.1 percentage of participants	68.7 percentage of participants
Vision Clarity During the Day - Distance Vision Exceeded my expectations	8.3 percentage of participants	8.3 percentage of participants	4.2 percentage of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Vision Clarity During the Day - Distance Vision Fell short of my expectations	16.7 percentage of participants	12.5 percentage of participants	18.8 percentage of participants
Vision Clarity During the Day - Distance Vision Met my expectations	64.5 percentage of participants	70.8 percentage of participants	64.5 percentage of participants
Vision Clarity During the Day - Distance Vision Exceeded my expectations	18.8 percentage of participants	16.7 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Number of Participants With Lens Centration Optimum	40 Participants	34 Participants	—
Number of Participants With Lens Centration Acceptable decentration	8 Participants	14 Participants	—
Number of Participants With Lens Centration Unacceptable decentration	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 3 weeks

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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Number of Participants With Lens Centration Optimum	32 Participants	—	—
Number of Participants With Lens Centration Acceptable decentration	16 Participants	—	—
Number of Participants With Lens Centration Unacceptable decentration	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Distance visual acuity (logMAR)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Visual Acuity Right Eye	0.10 logMar Standard Deviation 0.12	0.02 logMar Standard Deviation 0.11	—
Visual Acuity Both Eyes	-0.01 logMar Standard Deviation 0.09	-0.05 logMar Standard Deviation 0.08	—

SECONDARY outcome

Timeframe: 3 weeks

Distance visual acuity (logMAR)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Visual Acuity Both Eyes	-0.04 logMar Standard Deviation 0.09	—	—
Visual Acuity Right Eye	0.00 logMar Standard Deviation 0.09	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Post-blink Lens Movement Insufficient	0 percentage of particpants	0 percentage of particpants	—
Post-blink Lens Movement Minimal, but acceptable movement	20.8 percentage of particpants	8.3 percentage of particpants	—
Post-blink Lens Movement Optimal Movement	72.9 percentage of particpants	70.8 percentage of particpants	—
Post-blink Lens Movement Moderate, but acceptable Movement	6.3 percentage of particpants	20.8 percentage of particpants	—
Post-blink Lens Movement Excessive unacceptable	0 percentage of particpants	0 percentage of particpants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Post-blink Lens Movement Insufficient	0 percentage of participants	—	—
Post-blink Lens Movement Minimal, but acceptable movement	8.3 percentage of participants	—	—
Post-blink Lens Movement Optimal Movement	77.1 percentage of participants	—	—
Post-blink Lens Movement Moderate, but acceptable Movement	14.6 percentage of participants	—	—
Post-blink Lens Movement Excessive unacceptable	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Corneal Staining Temporal	1.15 units on a scale Standard Deviation 4.28	—	—
Corneal Staining Superior	1.15 units on a scale Standard Deviation 4.28	—	—
Corneal Staining Nasal	1.35 units on a scale Standard Deviation 5.03	—	—
Corneal Staining Inferior	2.81 units on a scale Standard Deviation 6.60	—	—
Corneal Staining Central	1.88 units on a scale Standard Deviation 6.87	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Corneal Staining Temporal	1.77 units on a scale Standard Deviation 7.75	—	—
Corneal Staining Superior	1.04 units on a scale Standard Deviation 3.57	—	—
Corneal Staining Nasal	1.15 units on a scale Standard Deviation 4.03	—	—
Corneal Staining Inferior	3.06 units on a scale Standard Deviation 9.54	—	—
Corneal Staining Central	0.75 units on a scale Standard Deviation 3.57	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Conjunctival Staining Temporal	10.31 units on a scale Standard Deviation 12.3	—	—
Conjunctival Staining Superior	7.70 units on a scale Standard Deviation 12.8	—	—
Conjunctival Staining Nasal	11.04 units on a scale Standard Deviation 13.0	—	—
Conjunctival Staining Inferior	9.69 units on a scale Standard Deviation 13.0	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Conjunctival Staining Temporal	16.87 units on a scale Standard Deviation 22.2	—	—
Conjunctival Staining Superior	7.60 units on a scale Standard Deviation 15.0	—	—
Conjunctival Staining Nasal	12.7 units on a scale Standard Deviation 17.2	—	—
Conjunctival Staining Inferior	11.8 units on a scale Standard Deviation 19.5	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Bulbar Hyperemia Bulbar Hyperemia	2.10 units on a scale Standard Deviation 0.65	—	—
Bulbar Hyperemia Limbal Hyperemia	1.90 units on a scale Standard Deviation 0.69	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Bulbar Hyperemia Bulbar Hyperemia	2.05 units on a scale Standard Deviation 0.57	—	—
Bulbar Hyperemia Limbal Hyperemia	1.90 units on a scale Standard Deviation 0.71	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Driving at Night Fell short of expectations	22.9 percentage of participants	—	—
Subjective Vision Satisfaction - Driving at Night Met expectations	68.8 percentage of participants	—	—
Subjective Vision Satisfaction - Driving at Night Exceeded expectations	8.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Driving at Night Fell short of expectations	16.7 percentage of participants	—	—
Subjective Vision Satisfaction - Driving at Night Met expectations	64.6 percentage of participants	—	—
Subjective Vision Satisfaction - Driving at Night Exceeded expectations	18.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Long Intermediate Vision Fell short of expectations	12.5 percentage of participants	—	—
Subjective Vision Satisfaction - Long Intermediate Vision Met expectations	85.4 percentage of participants	—	—
Subjective Vision Satisfaction - Long Intermediate Vision Exceeded expectation	2.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Long Intermediate Vision Fell short of expectations	8.3 percentage of participants	—	—
Subjective Vision Satisfaction - Long Intermediate Vision Met expectations	66.7 percentage of participants	—	—
Subjective Vision Satisfaction - Long Intermediate Vision Exceeded expectation	25.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Short Intermediate Tasks Fell short of expectations	22.9 percentage of participants	—	—
Subjective Vision Satisfaction - Short Intermediate Tasks Met expectations	70.8 percentage of participants	—	—
Subjective Vision Satisfaction - Short Intermediate Tasks Exceeded expectations	6.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Short Intermediate Tasks Fell short of expectations	14.6 percentage of participants	—	—
Subjective Vision Satisfaction - Short Intermediate Tasks Met expectations	62.5 percentage of participants	—	—
Subjective Vision Satisfaction - Short Intermediate Tasks Exceeded expectations	22.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Near Vision Fell short of expectations	43.8 percentage of participants	—	—
Subjective Vision Satisfaction - Near Vision Met expectations	50.0 percentage of participants	—	—
Subjective Vision Satisfaction - Near Vision Exceeded expectations	6.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Subjective Vision Satisfaction - Near Vision Fell short of expectations	16.7 percentage of participants	—	—
Subjective Vision Satisfaction - Near Vision Met expectations	56.3 percentage of participants	—	—
Subjective Vision Satisfaction - Near Vision Exceeded expectations	27.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Ease of Insertion Fell short of expectations	6.3 percentage of participants	—	—
Ease of Insertion Met expectations	81.3 percentage of participants	—	—
Ease of Insertion Exceeded expectations	12.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Ease of Insertion Fell short of expectations	6.3 percentage of participants	—	—
Ease of Insertion Met expectations	60.4 percentage of participants	—	—
Ease of Insertion Exceeded expectations	33.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Ease of Removal Fell short of expectations	4.2 percentage of participants	—	—
Ease of Removal Met expectations	83.3 percentage of participants	—	—
Ease of Removal Exceeded expectations	12.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Ease of Removal Fell short of expectations	14.6 percentage of participants	—	—
Ease of Removal Met expectations	62.5 percentage of participants	—	—
Ease of Removal Exceeded expectations	22.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Satisfaction With Speed of Changing Focus Fell short of expectations	12.5 percentage of participants	—	—
Overall Satisfaction With Speed of Changing Focus Met expectations	75.0 percentage of participants	—	—
Overall Satisfaction With Speed of Changing Focus Exceeded expectations	12.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Satisfaction With Speed of Changing Focus Fell short of expectations	6.3 percentage of participants	—	—
Overall Satisfaction With Speed of Changing Focus Met expectations	66.7 percentage of participants	—	—
Overall Satisfaction With Speed of Changing Focus Exceeded expectations	27.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Fell Short of expectations	18.8 percentage of participants	—	—
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Met expectations	68.8 percentage of participants	—	—
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Exceeded expectations	12.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 3 weeks

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

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Fell Short of expectations	14.6 percentage of participants	—	—
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Met expectations	58.3 percentage of participants	—	—
Overall Satisfaction Preference Between Study and Habitual Contact Lenses Exceeded expectations	27.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Comfort Prefer my own strongly	14.6 percentage of participants	—	—
Overall Comfort Prefer my own slightly	10.4 percentage of participants	—	—
Overall Comfort No preference	22.9 percentage of participants	—	—
Overall Comfort Prefer study lenses slightly	14.6 percentage of participants	—	—
Overall Comfort Prefer study lenses strongly	37.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Habitual Lens -Distance Vision While Driving During the Day n=48 Participants Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in Good Lighting. Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens	Habitual Lens - Distance Tasks in General Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle Prefer study lenses strongly	29.2 percentage of participants	—	—
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle Prefer my own strongly	14.5 percentage of participants	—	—
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle Prefer my own slightly	14.6 percentage of participants	—	—
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle No Preference	18.8 percentage of participants	—	—
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle Prefer study lenses slightly	22.9 percentage of participants	—	—

Adverse Events

Somofilcon A Multifocal Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose A. Vega, O.D., MSc., FAAO

CooperVision.Inc

Phone: 9256213761

Email: javega@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place