Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04016623
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Days): 29
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: 1-day toric test contact lens; Device: 1-day toric control contact lens	N/A

Detailed Description

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
• Actual Study Start Date: May 6, 2019
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1-day toric test contact lens Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).	Device: 1-day toric test contact lens; somofilcon A 1-day toric test contact lens; Other Names: Test contact lens Invigor toric 1-day contact lens ; Device: 1-day toric control contact lens; somofilcon A 1-day toric control contact lens; Other Names: Control contact lens
Active Comparator: 1-day toric control contact lens Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).	Device: 1-day toric test contact lens; somofilcon A 1-day toric test contact lens; Other Names: Test contact lens Invigor toric 1-day contact lens ; Device: 1-day toric control contact lens; somofilcon A 1-day toric control contact lens; Other Names: Control contact lens

Outcome Measures

Primary Outcome Measures

1. Visibility of Toric Mark [1 hour]

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

2. Degree of Lens Orientation [Baseline]

   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).

3. Degree of Lens Orientation [15 minutes]

   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).

4. Degree of Lens Orientation [1 hour]

   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).

5. Toric Stability [15 minutes]

   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).

6. Toric Stability [1 hour]

   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).

7. Degree of Rotational Recovery [15 minutes]

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

8. Degree of Rotational Recovery [1 hour]

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

9. Toric Fit Acceptance [15 minutes]

   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).

10. Toric Fit Acceptance [1 hour]

    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).

11. Toric Fit Preference [Baseline]

    Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

12. Toric Fit Preference [1 hour]

    Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Secondary Outcome Measures

1. Measurement of Lens Horizontal Centration [15 Minutes]

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

2. Measurement of Lens Horizontal Centration [1 hour]

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

3. Measurement of Lens Vertical Centration [15 minutes]

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

4. Measurement of Lens Vertical Centration [1 hour]

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

5. Measurement of Lens Movement [15 minutes]

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

6. Measurement of Lens Movement [1 hour]

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

7. Lens Push-Up [15 minutes]

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

8. Lens Push-Up [1 hour]

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

9. Primary Lens Gaze Lag [15 minutes]

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

10. Primary Lens Gaze Lag [1 hour]

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

11. General Lens Fit Acceptance [15 minutes]

    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).

12. General Lens Fit Acceptance [1 hour]

    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).

13. Up Gaze Lag [15 minutes]

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

14. Up Gaze Lag [1 hour]

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

15. General Lens Fit Preference [Baseline]

    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).

16. General Lens Fit Preference [1 hour]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has had a self-reported oculo-visual examination in the last two years.

• Is at least 18 years of age and has full legal capacity to volunteer.

• Has read and understood the information consent letter.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Currently wears soft contact lenses.

• Has clear corneas and no active ocular disease.

• Has not worn lenses for at least 12 hours before the examination

Exclusion Criteria:

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Pete S Kollbaum, OD PhD, Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 18, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04016623
• Other Study ID Numbers: CV-19-27
• First Posted: Jul 11, 2019
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Test Contact Lenses / Control Contact Lenses
Arm/Group Description	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
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: Pair 1 Test / Control Dispense
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (4)
Sex: Female, Male (Count of Participants)
Female	8 80%
Male	2 20%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Visibility of Toric Mark
Description	Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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).	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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Visible	100 1000%	100 NaN
Not Visible	0 0%	0 NaN

2. Primary Outcome

Title	Degree of Lens Orientation
Description	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).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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).	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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [Degrees]	0 (7)	-1 (7)

3. Primary Outcome

Title	Degree of Lens Orientation
Description	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).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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).	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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [Degrees]	1 (6)	0 (7)

4. Primary Outcome

Title	Degree of Lens Orientation
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 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).	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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [Degrees]	-1 (6)	-1 (6)

5. Primary Outcome

Title	Toric Stability
Description	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).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [Degrees]	4 (3)	4 (3)

6. Primary Outcome

Title	Toric Stability
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [Degrees]	5 (3)	4 (3)

7. Primary Outcome

Title	Degree of Rotational Recovery
Description	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure contact lenses	40	40
Nasal	16 (9)	15 (10)
Temporal	10 (10)	10 (9)

8. Primary Outcome

Title	Degree of Rotational Recovery
Description	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Inigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Nasal	16 (9)	12 (10)
Temporal	9 (10)	10 (10)

9. Primary Outcome

Title	Toric Fit Acceptance
Description	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).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lens
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [units on a scale]	3.5 (0.2)	3.4 (0.2)

10. Primary Outcome

Title	Toric Fit Acceptance
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [units on a scale]	3.5 (0.2)	3.4 (0.3)

11. Primary Outcome

Title	Toric Fit Preference
Description	Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Overall Study
Arm/Group Description	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. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measure Participants	10
Measure Contact Lenses	40
Test Lens	23
No Preference	69
Control Lens	8

12. Primary Outcome

Title	Toric Fit Preference
Description	Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Overall Study
Arm/Group Description	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. Data for all 4 pairs were combined and analyzed (n=40 Contact Lenses).
Measure Participants	10
Measure Contact Lenses	40
Test Lens	33
No Preference	57
Control Lens	10

13. Secondary Outcome

Title	Measurement of Lens Horizontal Centration
Description	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 Minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	-0.08 (0.24)	-0.05 (0.21)

14. Secondary Outcome

Title	Measurement of Lens Horizontal Centration
Description	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	-0.06 (0.22)	-0.08 (0.21)

15. Secondary Outcome

Title	Measurement of Lens Vertical Centration
Description	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. Both lens type and powers were randomized. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.34 (0.22)	0.34 (0.21)

16. Secondary Outcome

Title	Measurement of Lens Vertical Centration
Description	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.32 (0.19)	0.27 (0.26)

17. Secondary Outcome

Title	Measurement of Lens Movement
Description	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.26 (0.09)	0.25 (0.08)

18. Secondary Outcome

Title	Measurement of Lens Movement
Description	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.25 (0.08)	0.24 (0.08)

19. Secondary Outcome

Title	Lens Push-Up
Description	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [percentage]	45 (6)	47 (6)

20. Secondary Outcome

Title	Lens Push-Up
Description	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact Lenses	40	40
Mean (Standard Deviation) [percentage]	47 (5)	47 (6)

21. Secondary Outcome

Title	Primary Lens Gaze Lag
Description	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.20 (0.08)	0.21 (0.08)

22. Secondary Outcome

Title	Primary Lens Gaze Lag
Description	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.20 (0.06)	0.19 (0.08)

23. Secondary Outcome

Title	General Lens Fit Acceptance
Description	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).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [units on a scale]	3.4 (0.2)	3.4 (0.2)

24. Secondary Outcome

Title	General Lens Fit Acceptance
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure Contact lenses	40	40
Mean (Standard Deviation) [units on a scale]	3.4 (0.2)	3.4 (0.2)

25. Secondary Outcome

Title	Up Gaze Lag
Description	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lenses
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.25 (0.10)	0.25 (0.09)

26. Secondary Outcome

Title	Up Gaze Lag
Description	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Test Contact Lenses	Control Contact Lense
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens. Data for all 4 pairs were combined and analyzed (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. 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).
Measure Participants	10	10
Measure contact lenses	40	40
Mean (Standard Deviation) [millimeters (mm)]	0.22 (0.08)	0.22 (0.08)

27. Secondary Outcome

Title	General Lens Fit Preference
Description	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).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Overall Study
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens 1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measure Participants	10
Measure Contact lenses	40
Test Lens	5
No preference	92
Control lens	3

28. Secondary Outcome

Title	General Lens Fit Preference
Description	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).
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Overall Study
Arm/Group Description	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. 1-day toric test contact lens 1: Invigor 1-day toric test contact lens 1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measure Participants	10
Measure contact lenses	40
Test Lens	3
No preference	94
Control lens	3

Adverse Events

Time Frame	From dispense up to 1 hour on each pair of lenses.
Arm/Group Title	Test Contact Lenses		Control Contact Lenses
Arm/Group Description	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 the data was combined as 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. 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		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 the data was combined as 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. 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
All Cause Mortality
	Test Contact Lenses		Control Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Test Contact Lenses		Control Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Test Contact Lenses		Control Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.