A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04005885
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A	N/A

Detailed Description

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
• Primary Purpose: Other
• Official Title: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Nov 8, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A then stenfilcon A contact lens Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.	Device: comfilcon A; Contact Lens; Other Names: Control Lens ; Device: somofilcon A; daily disposable contact lens; Other Names: somofilcon A daily disposable test lens Test lens 1 ; Device: stenfilcon A; daily disposable contact lens; Other Names: stenfilcon A daily disposable test lens Test lens 2
Experimental: stenfilcon A then somofilcon A contact lens Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.	Device: comfilcon A; Contact Lens; Other Names: Control Lens ; Device: somofilcon A; daily disposable contact lens; Other Names: somofilcon A daily disposable test lens Test lens 1 ; Device: stenfilcon A; daily disposable contact lens; Other Names: stenfilcon A daily disposable test lens Test lens 2

Outcome Measures

Primary Outcome Measures

1. Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use [4 weeks]

   Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

2. Subjective Scores of Comfort on Insertion [1 week]

   Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Secondary Outcome Measures

1. Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use [4 weeks]

   Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

2. Subjective Scores on Overall Comfort [1 week]

   Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

3. Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use [4 weeks]

   Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

4. Subjective Scores on Comfort Before Removal [1 week]

   Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

5. Number of Participants With Horizontal Lens Centration Grade [Baseline (after 5 minutes of lens dispense)]

   Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

6. Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear [4 weeks]

   Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

7. Number of Participants With Horizontal Lens Centration Grade [1 week]

   Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

8. Number of Participants With Vertical Lens Centration Grade [Baseline (After 5 minutes of lens dispense)]

   Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

9. Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear [4 weeks]

   Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

10. Number of Participants With Vertical Lens Centration Grade [1 week]

    Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

11. Number of Participants With Lens Corneal Coverage Grade [Baseline (after 5 minutes of lens dispense)]

    Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

12. Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear [4 weeks]

    Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

13. Number of Participants With Lens Corneal Coverage Grade [1 week]

    Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

14. Number of Participants With Post-Blink Movement Grade [Baseline (after 5 minutes of lens dispense)]

    Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

15. Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear [4 weeks]

    Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

16. Number of Participants With Post-Blink Movement Grade [1 week]

    Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

17. Investigator Lens Fit Acceptance [Baseline (after 5 minutes of lens dispense)]

    Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

18. Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use [4 weeks]

    Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

19. Investigator Lens Fit Acceptance [1 week]

    Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects will only be eligible for the study if:

• They are between 18 and 40 years of age (inclusive).

• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

• They are willing and able to follow the protocol.

• They are an existing soft reusable spherical contact lens wearer in both eyes.

• They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.

• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction

• They own a wearable pair of spectacles and wear them on the day of the initial visit.

• They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.

• They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

• They have an ocular disorder which would normally contra-indicate contact lens wear.

• They have a systemic disorder which would normally contra-indicate contact lens wear.

• They are using any topical medication such as eye drops or ointment.

• They are aphakic.

• They have had corneal refractive surgery.

• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

• They are pregnant or breastfeeding.

• They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research - The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA, Eurolens Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 28, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04005885
• Other Study ID Numbers: EX-MKTG-100
• First Posted: Jul 2, 2019
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• 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.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	All subjects were fitted with comfilcon A for one month and then the subjects were randomized to wear two daily disposable lenses for one week.

Arm/Group Title	Somofilcon A, Then Stenfilcon A Contact Lens	Stenfilcon A, Then Somofilcon A Contact Lens
Arm/Group Description	All subjects fitted with the comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear the somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. comfilcon A : contact lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens	All subjects fitted with comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. comfilcon A: Contact Lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens
Period Title: First Intervention
STARTED	26	29
COMPLETED	25	28
NOT COMPLETED	1	1
Period Title: First Intervention
STARTED	25	28
COMPLETED	25	26
NOT COMPLETED	0	2
Period Title: First Intervention
STARTED	25	26
COMPLETED	25	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens and stenfilcon A daily disposable test lens each for 1 week of daily wear. comfilcon A: Contact Lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens
Overall Participants	55
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	55 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.1 (5.7)
Sex: Female, Male (Count of Participants)
Female	51 92.7%
Male	4 7.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	55 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Description	Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing visit.

Arm/Group Title	Comfilcon A
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Mean (Standard Deviation) [units on a scale]	89.9 (14.5)

2. Primary Outcome

Title	Subjective Scores of Comfort on Insertion
Description	Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Mean (Standard Deviation) [units on a scale]	90.3 (12.6)	90.4 (12.8)

3. Secondary Outcome

Title	Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Description	Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One Subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Mean (Standard Deviation) [units on a scale]	83.7 (15.5)

4. Secondary Outcome

Title	Subjective Scores on Overall Comfort
Description	Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Mean (Standard Deviation) [units on a scale]	84.0 (16.8)	85.7 (13.2)

5. Secondary Outcome

Title	Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Description	Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One Subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Mean (Standard Deviation) [units on a scale]	73.1 (20.2)

6. Secondary Outcome

Title	Subjective Scores on Comfort Before Removal
Description	Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Mean (Standard Deviation) [units on a scale]	77.6 (19.0)	79.3 (15.8)

7. Secondary Outcome

Title	Number of Participants With Horizontal Lens Centration Grade
Description	Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Contact Lens	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	55	51	53
Extremely nasal	0 0%	0 NaN	0 NaN
Slightly nasal	0 0%	2 NaN	2 NaN
Optimum	35 63.6%	19 NaN	33 NaN
Slightly Temporal	20 36.4%	30 NaN	18 NaN
Extremely Temporal	0 0%	0 NaN	0 NaN

8. Secondary Outcome

Title	Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Description	Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Extremely nasal	0 0%
Slightly nasal	1 1.8%
Optimum	32 58.2%
Slightly Temporal	21 38.2%
Extremely Temporal	0 0%

9. Secondary Outcome

Title	Number of Participants With Horizontal Lens Centration Grade
Description	Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Extremely nasal	0 0%	0 NaN
Slightly nasal	3 5.5%	1 NaN
Optimum	20 36.4%	30 NaN
Slightly Temporal	28 50.9%	21 NaN
Extremely Temporal	0 0%	0 NaN

10. Secondary Outcome

Title	Number of Participants With Vertical Lens Centration Grade
Description	Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame	Baseline (After 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Contact Lens	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	55	51	53
Extremely Inferior	0 0%	0 NaN	0 NaN
Slightly Inferior	12 21.8%	8 NaN	7 NaN
Optimum	35 63.6%	23 NaN	35 NaN
Slightly Superior	8 14.5%	20 NaN	11 NaN
Extremely Superior	0 0%	0 NaN	0 NaN

11. Secondary Outcome

Title	Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Description	Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Extremely Inferior	0 0%
Slightly Inferior	9 16.4%
Optimum	38 69.1%
Slightly Superior	7 12.7%
Extremely Superior	0 0%

12. Secondary Outcome

Title	Number of Participants With Vertical Lens Centration Grade
Description	Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Extremely Inferior	0 0%	0 NaN
Slightly Inferior	10 18.2%	4 NaN
Optimum	22 40%	37 NaN
Slightly Superior	19 34.5%	11 NaN
Extremely Superior	0 0%	0 NaN

13. Secondary Outcome

Title	Number of Participants With Lens Corneal Coverage Grade
Description	Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Contact Lens	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	55	51	53
Extremely Inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	3 5.5%	23 NaN	1 NaN
Optimum	48 87.3%	26 NaN	46 NaN
Slightly excessive	4 7.3%	2 NaN	6 NaN
Extremely excessive	0 0%	0 NaN	0 NaN

14. Secondary Outcome

Title	Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Description	Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing Visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Extremely Inadequate	0 0%
Slightly inadequate	4 7.3%
Optimum	43 78.2%
Slightly excessive	6 10.9%
Extremely excessive	1 1.8%

15. Secondary Outcome

Title	Number of Participants With Lens Corneal Coverage Grade
Description	Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Extremely Inadequate	0 0%	0 NaN
Slightly inadequate	20 36.4%	3 NaN
Optimum	30 54.5%	43 NaN
Slightly excessive	1 1.8%	6 NaN
Extremely excessive	0 0%	0 NaN

16. Secondary Outcome

Title	Number of Participants With Post-Blink Movement Grade
Description	Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Contact Lens	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	55	51	53
Extremely inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	11 20%	6 NaN	7 NaN
Optimum	35 63.6%	33 NaN	31 NaN
Slightly excessive	9 16.4%	12 NaN	15 NaN
Extremely excessive	0 0%	0 NaN	0 NaN

17. Secondary Outcome

Title	Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Description	Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Extremely inadequate	0 0%
Slightly inadequate	6 10.9%
Optimum	38 69.1%
Slightly excessive	10 18.2%
Extremely excessive	0 0%

18. Secondary Outcome

Title	Number of Participants With Post-Blink Movement Grade
Description	Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Extremely inadequate	0 0%	0 NaN
Slightly inadequate	5 9.1%	5 NaN
Optimum	34 61.8%	28 NaN
Slightly excessive	12 21.8%	19 NaN
Extremely excessive	0 0%	0 NaN

19. Secondary Outcome

Title	Investigator Lens Fit Acceptance
Description	Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Contact Lens	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	55	51	53
Acceptable Fits	100	100	100
Optimum Fits	27	16	28

20. Secondary Outcome

Title	Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Description	Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

One subject discontinued after dispensing visit

Arm/Group Title	Comfilcon A Contact Lens
Arm/Group Description	Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens
Measure Participants	54
Acceptable Fits	98
Optimum Fits	33

21. Secondary Outcome

Title	Investigator Lens Fit Acceptance
Description	Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A Contact Lens	Stenfilcon A Contact Lens
Arm/Group Description	Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens	Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
Measure Participants	51	52
Acceptable Fits	100	100
Optimum Fits	10	21

Adverse Events

Time Frame	From dispense up to 4 weeks for comfilcon A contact lens and from dispense up to one week for somofilcon A and stenfilcon A contact lens, up to 6 weeks total.
Adverse Event Reporting Description	Two subjects discontinued from somofilcon A intervention after dispensing. 53 subjects were considered at risk for adverse events for Somofilcon A Contact Lens Arm/Group..
Arm/Group Title	Comfilcon A Contact Lens		Somofilcon A Contact Lens		Stenfilcon A Contact Lens
Arm/Group Description	All participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens		Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens		Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens
All Cause Mortality
	Comfilcon A Contact Lens		Somofilcon A Contact Lens		Stenfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/53 (0%)		0/53 (0%)
Serious Adverse Events
	Comfilcon A Contact Lens		Somofilcon A Contact Lens		Stenfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/53 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A Contact Lens		Somofilcon A Contact Lens		Stenfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/53 (0%)		0/53 (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.