Trial Outcomes & Findings for Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear (NCT NCT04050605)

NCT ID: NCT04050605

Last Updated: 2020-09-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-09-09

Participant Flow

Participant milestones

Measure	Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test) Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens
Overall Study STARTED	40
Overall Study COMPLETED	40
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	Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test) n=40 Participants Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants
Age, Continuous	25.1 years STANDARD_DEVIATION 6.8 • n=40 Participants
Sex: Female, Male Female	27 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=40 Participants
Region of Enrollment Mexico	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Lens Centration - Somofilcon A Toric (Habitual) Lens Optimum	100 percentage of lenses
Lens Centration - Somofilcon A Toric (Habitual) Lens Acceptable	0 percentage of lenses
Lens Centration - Somofilcon A Toric (Habitual) Lens Unacceptable	0 percentage of lenses

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Lens Centration - Somofilcon A Toric (Habitual) Lens Optimum	100 percentage of lenses
Lens Centration - Somofilcon A Toric (Habitual) Lens Acceptable	0 percentage of lenses
Lens Centration - Somofilcon A Toric (Habitual) Lens Unacceptable	0 percentage of lenses

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Lens Centration - Fanfilcon A Toric Lens Optimum	100 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Acceptable	0 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Unacceptable	0 percentage of lenses

PRIMARY outcome

Timeframe: 2-weeks

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

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Lens Centration - Fanfilcon A Toric Lens Optimum	100 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Acceptable	0 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Unacceptable	0 percentage of lenses

PRIMARY outcome

Timeframe: 4-weeks

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

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Lens Centration - Fanfilcon A Toric Lens Optimum	100 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Acceptable	0 percentage of lenses
Lens Centration - Fanfilcon A Toric Lens Unacceptable	0 percentage of lenses

PRIMARY outcome

Timeframe: Baseline

Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens Yes	100 percentage of lenses
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens No	0 percentage of lenses

PRIMARY outcome

Timeframe: 4-weeks

Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens Yes	100 percentage of lenses
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens No	0 percentage of lenses

PRIMARY outcome

Timeframe: Baseline

Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Corneal Coverage - Fanfilcon A Toric Lens Yes	100 percentage of lenses
Corneal Coverage - Fanfilcon A Toric Lens No	0 percentage of lenses

PRIMARY outcome

Timeframe: 2-weeks

Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Corneal Coverage - Fanfilcon A Toric Lens Yes	100 percentage of lenses
Corneal Coverage - Fanfilcon A Toric Lens No	0 percentage of lenses

PRIMARY outcome

Timeframe: 4-weeks

Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Corneal Coverage - Fanfilcon A Toric Lens Yes	100 percentage of lenses
Corneal Coverage - Fanfilcon A Toric Lens No	0 percentage of lenses

PRIMARY outcome

Timeframe: Baseline

Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 4-weeks

Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline

Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Post-Blink Movement - Fanfilcon A Toric Lens	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 2-weeks

Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Post-Blink Movement - Fanfilcon A Toric Lens	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 4-weeks

Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Post-Blink Movement - Fanfilcon A Toric Lens	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Baseline

Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens	3.8 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 4-weeks

Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens	3.8 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline

Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	3.9 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: 2-weeks

Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4-weeks

Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens	4.0 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 weeks

Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens	10.4 hours/day Standard Deviation 3.0

SECONDARY outcome

Timeframe: 2 weeks

Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Daily Wearing Time - Fanfilcon A Toric Lens	10.5 hours/day Standard Deviation 2.7

SECONDARY outcome

Timeframe: 4 weeks

Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Daily Wearing Time - Fanfilcon A Toric Lens	10.9 hours/day Standard Deviation 2.6

SECONDARY outcome

Timeframe: 4 weeks

Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens	8.4 hours/day Standard Deviation 3.5

SECONDARY outcome

Timeframe: 2 weeks

Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Comfortable Wearing Time - Fanfilcon A Toric Lens	9.0 hours/day Standard Deviation 2.6

SECONDARY outcome

Timeframe: 4 weeks

Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.

Outcome measures

Measure	Somofilcon A Toric (Habitual) n=40 Participants Participants wore their habitual somofilcon A toric lens for 4-weeks. somofilcon A toric contact lens: Contact Lens
Average Comfortable Wearing Time - Fanfilcon A Toric Lens	9.6 hours/day Standard Deviation 2.6

Adverse Events

Somofilcon A Toric (Habitual) Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fanfilcon A Toric Contact 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