Trial Outcomes & Findings for Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear (NCT NCT03974802)

NCT ID: NCT03974802

Last Updated: 2020-08-18

Results Overview

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-08-18

Participant Flow

Participant milestones

Measure	Somofilcon A (Habitual) Lens, Then Fanfilcon A (Test) Lens Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks. somofilcon A contact lens: Contact Lens fanfilcon A contact lens: Contact Lens
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=41 Participants Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks. somofilcon A contact lens: Contact Lens fanfilcon A contact lens: Contact Lens
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 7.2 • n=41 Participants
Sex: Female, Male Female	31 Participants n=41 Participants
Sex: Female, Male Male	10 Participants n=41 Participants
Region of Enrollment Mexico	41 participants n=41 Participants

PRIMARY outcome

Timeframe: Baseline

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Centration for Somofilcon A (Habitual) Lens Optimum	100 percentage of participants
Lens Centration for Somofilcon A (Habitual) Lens Decentration Acceptable	0 percentage of participants
Lens Centration for Somofilcon A (Habitual) Lens Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 4- weeks

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Centration for Somofilcon A (Habitual) Lens Optimum	100 percentage of participants
Lens Centration for Somofilcon A (Habitual) Lens Decentartion Acceptable	0 percentage of participants
Lens Centration for Somofilcon A (Habitual) Lens Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Centration for Fanfilcon A (Test) Lens Optimum	100 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Acceptable	0 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 2-weeks

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Centration for Fanfilcon A (Test) Lens Optimum	100 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Acceptable	0 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 4- weeks

Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Centration for Fanfilcon A (Test) Lens Optimum	100 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Acceptable	0 percentage of participants
Lens Centration for Fanfilcon A (Test) Lens Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Corneal Coverage for Somofilcon A (Habitual) Lens Yes	100 percentage of participants
Lens Corneal Coverage for Somofilcon A (Habitual) Lens No	0 percentage of participants

PRIMARY outcome

Timeframe: 4 -weeks

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Corneal Coverage for Somofilcon A (Habitual) Lens Yes	100 percentage of participants
Lens Corneal Coverage for Somofilcon A (Habitual) Lens No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Corneal Coverage for Fanfilcon A (Test) Lens Yes	100 percentage of participants
Lens Corneal Coverage for Fanfilcon A (Test) Lens No	0 percentage of participants

PRIMARY outcome

Timeframe: 2-weeks

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Corneal Coverage for Fanfilcon A (Test) Lens Yes	100 percentage of participants
Lens Corneal Coverage for Fanfilcon A (Test) Lens No	0 percentage of participants

PRIMARY outcome

Timeframe: 4-weeks

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Lens Corneal Coverage for Fanfilcon A (Test) Lens Yes	100 percentage of participants
Lens Corneal Coverage for Fanfilcon A (Test) Lens No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	51.7 units on a scale Standard Deviation 5.0

PRIMARY outcome

Timeframe: 4-Weeks

Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	51.8 units on a scale Standard Deviation 5.0

PRIMARY outcome

Timeframe: Baseline

Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	50.5 units on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 2-Weeks

Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	50.4 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 4-Weeks

Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	50.2 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline

Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Post-Blink Movement for Somofilcon A (Habitual) Lens	1.95 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4-weeks

Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Post-Blink Movement for Somofilcon A (Habitual) Lens	1.95 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: Baseline

Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Post-Blink Movement for Fanfilcon A (Test) Lens	1.95 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2-weeks

Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Post-Blink Movement for Fanfilcon A (Test) Lens	2.00 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 4-weeks

Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Post-Blink Movement for Fanfilcon A (Test) Lens	2.00 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	3.85 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: 4-weeks

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	3.83 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.95 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2-weeks

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.98 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4-weeks

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.98 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4-weeks

Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Daily Wearing Time - Somofilcon A (Habitual) Lens	12.1 hours/day Standard Deviation 3.1

SECONDARY outcome

Timeframe: 2-weeks

Average daily wearing time for fanfilcon A (test) lens was measured in hours/day

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Daily Wearing Time - Fanfilcon A (Test) Lens	12.3 hours/day Standard Deviation 2.0

SECONDARY outcome

Timeframe: 4-weeks

Average daily wearing time for fanfilcon A (test) lens was measured in hours/day

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Daily Wearing Time - Fanfilcon A (Test) Lens	12.3 hours/day Standard Deviation 2.0

SECONDARY outcome

Timeframe: 4 weeks

Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens	9.8 hours/day Standard Deviation 3.3

SECONDARY outcome

Timeframe: 2 weeks

Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	10.6 hours/day Standard Deviation 2.2

SECONDARY outcome

Timeframe: 4 weeks

Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.

Outcome measures

Measure	Somofilcon A (Habitual) Lens n=41 Participants Participants wore their habitual somofilcon A lens for 4-weeks. somofilcon A: Contact lens
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	10.8 hours/day Standard Deviation 1.8

Adverse Events

Somofilcon A (Habitual) Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fanfilcon A (Test) 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