Trial Outcomes & Findings for Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks (NCT NCT03835078)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Baseline

Results posted on

2020-06-11

Participant Flow

42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.

Participant milestones

Participant milestones
Measure	Methalfilcon A Contact Lenses / Fanfilcon A Contact Lenses All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses
Overall Study STARTED	39
Overall Study COMPLETED	39
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

Baseline characteristics by cohort
Measure	Overall Study n=39 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	25.3 years STANDARD_DEVIATION 6.7 • n=39 Participants
Sex: Female, Male Female	24 Participants n=39 Participants
Sex: Female, Male Male	15 Participants n=39 Participants
Region of Enrollment Mexico	39 participants n=39 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Optimal Centration	100 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Decentration Acceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Decentartion Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Decentration Acceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Decentration Unacceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses Optimal Centration	100 percentage of participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Optimal Centration	100 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentration Acceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Optimal Centration	100 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentration Acceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Optimal Centration	100 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentartion Acceptable	0 percentage of participants
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses Decentration Unacceptable	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses Yes	97.4 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses No	2.6 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: 2 weeks

Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Post-blink movement, was rated at each visit using a 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

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	1.90 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: 4 weeks

Post-blink movement, was rated at each visit using a 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

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	1.95 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline

Post-blink movement, was rated at each visit using a 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

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	1.97 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2 weeks

Post-blink movement, was rated at each visit using a 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

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	1.97 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4 weeks

Post-blink movement, was rated at each visit using a 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

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	2.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: Baseline

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	53.59 units on a scale Standard Deviation 9.6

PRIMARY outcome

Timeframe: 4 weeks

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	52.31 units on a scale Standard Deviation 6.5

PRIMARY outcome

Timeframe: Baseline

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.38 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 2 weeks

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.64 units on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: 4 weeks

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.51 units on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: Baseline

Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	3.69 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 4 weeks

Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	3.74 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline

Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.97 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2 weeks

Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.92 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: 4 weeks

Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.95 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 4 weeks

Average daily wearing time response by the subject

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Daily Wearing Time - Methafilcon A Contact Lenses	12.1 hours / day Standard Deviation 4.0

SECONDARY outcome

Timeframe: 2 weeks

Average daily wearing time response by the subject.

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Daily Wearing Time - Fanfilcon A Contact Lenses	12.2 hours / day Standard Deviation 2.6

SECONDARY outcome

Timeframe: 4 weeks

Average daily wearing time response by the subject

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Daily Wearing Time - Fanfilcon A Contact Lenses	12.3 hours / day Standard Deviation 2.6

SECONDARY outcome

Timeframe: 4 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Comfortable Wearing Time - Methafilcon A Contact Lenses	10.0 hours / day Standard Deviation 3.2

SECONDARY outcome

Timeframe: 2 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	9.6 hours / day Standard Deviation 3.0

SECONDARY outcome

Timeframe: 4 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Outcome measures
Measure	Methalfilcon A Contact Lenses n=39 Participants All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	9.7 hours / day Standard Deviation 2.9

Adverse Events

Methafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fanfilcon A

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place