Trial Outcomes & Findings for Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month (NCT NCT03835221)

NCT ID: NCT03835221

Last Updated: 2020-06-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-06-11

Participant Flow

Participant milestones

Measure	Methafilcon A / Fanfilcon A Contact Lenses All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A 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
Methafilcon A STARTED	43
Methafilcon A COMPLETED	42
Methafilcon A NOT COMPLETED	1
Fanfilcon A STARTED	42
Fanfilcon A COMPLETED	42
Fanfilcon A NOT COMPLETED	0

Reasons for withdrawal

Measure	Methafilcon A / Fanfilcon A Contact Lenses All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A 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
Methafilcon A Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=43 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=43 Participants
Age, Continuous	24.2 years STANDARD_DEVIATION 6.9 • n=43 Participants
Sex: Female, Male Female	26 Participants n=43 Participants
Sex: Female, Male Male	17 Participants n=43 Participants
Region of Enrollment Mexico	43 participants n=43 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Methafilcon A n=43 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
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Optimal Centration	40 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Decentration acceptable	3 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Decentration unacceptable	0 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Optimal centration	41 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Decentration acceptable	1 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses Decentration unacceptable	0 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Methafilcon A n=42 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
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Optimal centration	42 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration acceptable	0 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration unacceptable	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Optimal centration	42 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration acceptable	0 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration unacceptable	0 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Optimal centration	42 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration acceptable	0 Participants
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses Decentration unacceptable	0 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Methafilcon A n=43 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 Toric Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses Yes	100 percentage of participants
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses No	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Methafilcon A n=43 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 Toric Contact Lenses	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 4 weeks

Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	1.97 units on a scale Standard Deviation 0.15

PRIMARY outcome

Timeframe: Baseline

Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	2.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 2 weeks

Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	1.97 units on a scale Standard Deviation 0.15

PRIMARY outcome

Timeframe: 4 weeks

Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	1.97 units on a scale Standard Deviation 0.15

PRIMARY outcome

Timeframe: Baseline

Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

Outcome measures

Measure	Methafilcon A n=43 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	2.21 Degrees Standard Deviation 4.0

PRIMARY outcome

Timeframe: 4 weeks

Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

Outcome measures

Measure	Methafilcon A n=42 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	1.55 Degrees Standard Deviation 3.2

PRIMARY outcome

Timeframe: Baseline

Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

Outcome measures

Measure	Methafilcon A n=42 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.71 Degrees Standard Deviation 1.8

PRIMARY outcome

Timeframe: 2 weeks

Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

Outcome measures

Measure	Methafilcon A n=42 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.71 Degrees Standard Deviation 1.8

PRIMARY outcome

Timeframe: 4 weeks

Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.

Outcome measures

Measure	Methafilcon A n=42 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.47 Degrees Standard Deviation 1.9

PRIMARY outcome

Timeframe: Baseline

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Outcome measures

Measure	Methafilcon A n=43 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
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	2.79 Degrees Standard Deviation 4.8

PRIMARY outcome

Timeframe: 4 weeks

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Outcome measures

Measure	Methafilcon A n=42 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
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	2.02 Degrees Standard Deviation 3.5

PRIMARY outcome

Timeframe: Baseline

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Outcome measures

Measure	Methafilcon A n=42 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
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.83 Degrees Standard Deviation 2.2

PRIMARY outcome

Timeframe: 2 weeks

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Outcome measures

Measure	Methafilcon A n=42 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
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.95 Degrees Standard Deviation 2.3

PRIMARY outcome

Timeframe: 4 weeks

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Outcome measures

Measure	Methafilcon A n=42 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
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.48 Degrees Standard Deviation 1.5

PRIMARY outcome

Timeframe: Baseline

Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

Outcome measures

Measure	Methafilcon A n=43 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 Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	3.8 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: 4 weeks

Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

Outcome measures

Measure	Methafilcon A n=42 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 Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	3.8 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline

Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

Outcome measures

Measure	Methafilcon A n=42 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2 weeks

Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

Outcome measures

Measure	Methafilcon A n=42 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4 weeks

Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).

Outcome measures

Measure	Methafilcon A n=42 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: Baseline

Overall lens fit acceptance assessed using grade (0-4) 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

Measure	Methafilcon A n=43 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 Toric Contact Lenses	3.8 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: 4 weeks

Overall lens fit acceptance assessed using grade (0-4) 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

Measure	Methafilcon A n=42 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 Toric Contact Lenses	3.8 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline

Overall lens fit acceptance assessed using grade (0-4) 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

Measure	Methafilcon A n=42 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 Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2 weeks

Overall lens fit acceptance assessed using grade (0-4) 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

Measure	Methafilcon A n=42 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 Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 4 weeks

Overall lens fit acceptance assessed using grade (0-4) 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

Measure	Methafilcon A n=42 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 Toric Contact Lenses	4.0 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 weeks

Average daily wearing time response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	10.4 hours / day Standard Deviation 2.8

SECONDARY outcome

Timeframe: 2 weeks

Average daily wearing time response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	10.6 hours/day Standard Deviation 2.8

SECONDARY outcome

Timeframe: 4 weeks

Average daily wearing time response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	11.0 hours/day Standard Deviation 2.8

SECONDARY outcome

Timeframe: 4 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	7.6 hours/day Standard Deviation 2.8

SECONDARY outcome

Timeframe: 2 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	8.1 hours/day Standard Deviation 2.9

SECONDARY outcome

Timeframe: 4 weeks

Average comfortable wearing time - response by the subject

Outcome measures

Measure	Methafilcon A n=42 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 Toric Contact Lenses	8.6 hours/day Standard Deviation 3.1

Adverse Events

Methafilcon A Toric Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fanfilcon A Toric Contact Lenses

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