Trial Outcomes & Findings for Clinical Evaluation of Invigor Toric 1-Day Contact Lenses (NCT NCT04016623)

NCT ID: NCT04016623

Last Updated: 2020-08-14

Results Overview

Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2020-08-14

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Test Contact Lenses / Control Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye for 1 hour. Four different powers of test and control lens were used. There was a 15-minute wash-out period between the two lens pairs 1-day toric test contact lens 1: Invigor 1-day toric test contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090 1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090
Pair 1 Test / Control Dispense STARTED	10 20
Pair 1 Test / Control Dispense COMPLETED	10 20
Pair 1 Test / Control Dispense NOT COMPLETED	0 0
Pair 1 Test /Control Follow up STARTED	10 20
Pair 1 Test /Control Follow up COMPLETED	10 20
Pair 1 Test /Control Follow up NOT COMPLETED	0 0
Pair 2 Test / Control Dispense STARTED	10 20
Pair 2 Test / Control Dispense COMPLETED	10 20
Pair 2 Test / Control Dispense NOT COMPLETED	0 0
Pair 2 Test /Control Follow up STARTED	10 20
Pair 2 Test /Control Follow up COMPLETED	10 20
Pair 2 Test /Control Follow up NOT COMPLETED	0 0
Pair 3 Test / Control Dispense STARTED	10 20
Pair 3 Test / Control Dispense COMPLETED	10 20
Pair 3 Test / Control Dispense NOT COMPLETED	0 0
Pair 3 Test /Control Follow up STARTED	10 20
Pair 3 Test /Control Follow up COMPLETED	10 20
Pair 3 Test /Control Follow up NOT COMPLETED	0 0
Pair 4 Test / Control Dispense STARTED	10 20
Pair 4 Test / Control Dispense COMPLETED	10 20
Pair 4 Test / Control Dispense NOT COMPLETED	0 0
Pair 4 Test /Control Follow up STARTED	10 20
Pair 4 Test /Control Follow up COMPLETED	10 20
Pair 4 Test /Control Follow up NOT COMPLETED	0 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=10 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	25 years STANDARD_DEVIATION 4 • n=10 Participants
Sex: Female, Male Female	8 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Visibility of Toric Mark Visible	100 percentage of participants	100 percentage of participants
Visibility of Toric Mark Not Visible	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation	0 Degrees Standard Deviation 7	-1 Degrees Standard Deviation 7

PRIMARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation	1 Degrees Standard Deviation 6	0 Degrees Standard Deviation 7

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation	-1 Degrees Standard Deviation 6	-1 Degrees Standard Deviation 6

PRIMARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability	4 Degrees Standard Deviation 3	4 Degrees Standard Deviation 3

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability	5 Degrees Standard Deviation 3	4 Degrees Standard Deviation 3

PRIMARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery Nasal	16 Degrees Standard Deviation 9	15 Degrees Standard Deviation 10
Degree of Rotational Recovery Temporal	10 Degrees Standard Deviation 10	10 Degrees Standard Deviation 9

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery Nasal	16 Degrees Standard Deviation 9	12 Degrees Standard Deviation 10
Degree of Rotational Recovery Temporal	9 Degrees Standard Deviation 10	10 Degrees Standard Deviation 10

PRIMARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance	3.5 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance	3.5 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Investigator's toric fitting preference - Test lens , No Preference , Control lens.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference Test Lens	23 percentage of eyes	—
Toric Fit Preference No Preference	69 percentage of eyes	—
Toric Fit Preference Control Lens	8 percentage of eyes	—

PRIMARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Investigator's toric fitting preference - Test lens, No Preference, Control lens.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference Test Lens	33 percentage of eyes	—
Toric Fit Preference No Preference	57 percentage of eyes	—
Toric Fit Preference Control Lens	10 percentage of eyes	—

SECONDARY outcome

Timeframe: 15 Minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Horizontal Centration	-0.08 millimeters (mm) Standard Deviation 0.24	-0.05 millimeters (mm) Standard Deviation 0.21

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Horizontal Centration	-0.06 millimeters (mm) Standard Deviation 0.22	-0.08 millimeters (mm) Standard Deviation 0.21

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Vertical Centration	0.34 millimeters (mm) Standard Deviation 0.22	0.34 millimeters (mm) Standard Deviation 0.21

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Vertical Centration	0.32 millimeters (mm) Standard Deviation 0.19	0.27 millimeters (mm) Standard Deviation 0.26

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Movement	0.26 millimeters (mm) Standard Deviation 0.09	0.25 millimeters (mm) Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Movement	0.25 millimeters (mm) Standard Deviation 0.08	0.24 millimeters (mm) Standard Deviation 0.08

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Lens Push-Up	45 percentage Standard Deviation 6	47 percentage Standard Deviation 6

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Lens Push-Up	47 percentage Standard Deviation 5	47 percentage Standard Deviation 6

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Primary Lens Gaze Lag	0.20 millimeters (mm) Standard Deviation 0.08	0.21 millimeters (mm) Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Primary Lens Gaze Lag	0.20 millimeters (mm) Standard Deviation 0.06	0.19 millimeters (mm) Standard Deviation 0.08

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Acceptance	3.4 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Acceptance	3.4 units on a scale Standard Deviation 0.2	3.4 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 15 minutes

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Up Gaze Lag	0.25 millimeters (mm) Standard Deviation 0.10	0.25 millimeters (mm) Standard Deviation 0.09

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Up Gaze Lag	0.22 millimeters (mm) Standard Deviation 0.08	0.22 millimeters (mm) Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Investigator's general lens fit preference - Test lens, No preference, Control lens.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 Contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Preference Control lens	3 percentage of eyes	—
General Lens Fit Preference Test Lens	5 percentage of eyes	—
General Lens Fit Preference No preference	92 percentage of eyes	—

SECONDARY outcome

Timeframe: 1 hour

Population: The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses.

Investigator's general lens fit preference - Test lens, No preference, Control lens.

Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Outcome measures

Measure	Test Contact Lenses n=40 contact lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric test contact lens: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Control Contact Lenses Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Preference Test Lens	3 percentage of eyes	—
General Lens Fit Preference No preference	94 percentage of eyes	—
General Lens Fit Preference Control lens	3 percentage of eyes	—

Adverse Events

Test Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control 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

Myhanh Nguyen

CooperVision, Inc.

Phone: 925-730-6716

Email: mnguyen@coopervision.com

Results disclosure agreements

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