The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04067141
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 15.3

Study Details

Study Description

Brief Summary

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: somofilcon A; Device: nelfilcon A	N/A

Detailed Description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is a bilateral crossover studyThis is a bilateral crossover study
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses
• Actual Study Start Date: Jul 4, 2019
• Actual Primary Completion Date: Nov 5, 2019
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A, then nelfilcon A Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.	Device: somofilcon A; Contact Lens; Other Names: somofilcon A 1 day test lens clariti 1 day ; Device: nelfilcon A; Contact Lens; Other Names: nelfilcon A Daily Disposable Contact Lens control lens DAILIES AquaComfort PLUS daily disposable
Experimental: nelfilcon A, then somofilcon A Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.	Device: somofilcon A; Contact Lens; Other Names: somofilcon A 1 day test lens clariti 1 day ; Device: nelfilcon A; Contact Lens; Other Names: nelfilcon A Daily Disposable Contact Lens control lens DAILIES AquaComfort PLUS daily disposable

Outcome Measures

Primary Outcome Measures

1. Subjective Comfort at Lens Dispensing [Baseline (after 5 minutes of lens dispense)]

   Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

2. Subjective Comfort at Start of Day [1 week]

   Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

3. Subjective Comfort at End of Day [1 week]

   Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

4. Overall Subjective Comfort [Baseline (after 5 minutes of lens dispense)]

   Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

5. Overall Subjective Comfort [1 week]

   Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

6. Subjective Vision [Baseline (after 5 minutes of lens dispense)]

   Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

7. Subjective Vision [1 week]

   Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

Secondary Outcome Measures

1. Biomicroscopy - Conjunctival Redness Score [One Week]

   Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

2. Biomicroscopy - Limbal Redness Score [One week]

   Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

3. Biomicroscopy - Corneal Staining Score [One week]

   Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

4. Biomicroscopy - Conjunctival Staining Score [One week]

   Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

5. Biomicroscopy - Papillary Conjunctivitis Score [One week]

   Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

6. Horizontal Centration - Lens Fit [Baseline (after 5 minutes of lens dispense)]

   Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).

7. Horizontal Centration - Lens Fit [One Week]

   Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).

8. Vertical Centration Grade - Lens Fit [Baseline (after 5 minutes of lens dispense)]

   Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).

9. Vertical Centration Grade - Lens Fit [One week]

   Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).

10. Corneal Coverage Grade [Baseline (after 5 minutes of lens dispense)]

    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

11. Corneal Coverage Grade [One week]

    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

12. Post-Blink Movement Grade [Baseline (after 5 minutes of lens dispense)]

    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

13. Post-Blink Movement Grade [1 week]

    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

14. Ocular Redness Rating [1 week]

    Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• They are of legal age (18) and capacity to volunteer.

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

• They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)

• They have a maximum of -1.00DC ocular astigmatism in each eye.

• They can be satisfactorily fitted with the study lens types.

• At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

• They currently use soft contact lenses or have done so in the previous six months.

• They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

• They own a wearable pair of spectacles.

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 have had cataract surgery.

• 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 breast-feeding.

• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

• 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.

• They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 6, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04067141
• Other Study ID Numbers: EX-MKTG-75
• First Posted: Aug 26, 2019
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 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.: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Somofilcon A, Then Nelfilcon A	Nelfilcon A, Then Somofilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. somofilcon A: Contact Lens nelfilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. somofilcon A: Contact Lens nelfilcon A: Contact Lens
Period Title: First Intervention
STARTED	35	35
COMPLETED	35	34
NOT COMPLETED	0	1
Period Title: First Intervention
STARTED	34	33
COMPLETED	34	31
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear somofilcon A 1 day and nelfilcon A for one week in this cross-over study.
Overall Participants	70
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	70 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (10.0)
Sex: Female, Male (Count of Participants)
Female	55 78.6%
Male	15 21.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	70 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Comfort at Lens Dispensing
Description	Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	69
Mean (Standard Deviation) [units on a scale]	90.9 (11.6)	88.5 (12.8)

2. Primary Outcome

Title	Subjective Comfort at Start of Day
Description	Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	89.9 (13.8)	87.0 (14.7)

3. Primary Outcome

Title	Subjective Comfort at End of Day
Description	Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	75.9 (22.1)	68.0 (25.5)

4. Primary Outcome

Title	Overall Subjective Comfort
Description	Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	69
Mean (Standard Deviation) [units on a scale]	90.4 (10.1)	90.9 (10.8)

5. Primary Outcome

Title	Overall Subjective Comfort
Description	Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	86.1 (14.1)	78.8 (19.8)

6. Primary Outcome

Title	Subjective Vision
Description	Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	69
Mean (Standard Deviation) [units on a scale]	92.8 (10.1)	94.2 (7.8)

7. Primary Outcome

Title	Subjective Vision
Description	Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	90.9 (12.1)	92.1 (13.2)

8. Secondary Outcome

Title	Biomicroscopy - Conjunctival Redness Score
Description	Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time Frame	One Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	0.85 (0.25)	0.87 (0.25)

9. Secondary Outcome

Title	Biomicroscopy - Limbal Redness Score
Description	Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	0.74 (0.27)	0.79 (0.28)

10. Secondary Outcome

Title	Biomicroscopy - Corneal Staining Score
Description	Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	0.33 (0.43)	0.32 (0.40)

11. Secondary Outcome

Title	Biomicroscopy - Conjunctival Staining Score
Description	Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	1.46 (0.71)	0.35 (0.36)

12. Secondary Outcome

Title	Biomicroscopy - Papillary Conjunctivitis Score
Description	Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	1.02 (0.20)	1.03 (0.18)

13. Secondary Outcome

Title	Horizontal Centration - Lens Fit
Description	Horizontal centration graded by -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	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	70
Extremely nasal	0	0
Slightly nasal	6	6
Optimum	51	63
Slightly temporal	43	31
Extremely temporal	0	0

14. Secondary Outcome

Title	Horizontal Centration - Lens Fit
Description	Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
Time Frame	One Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	66	68
Measure eyes	132	136
Extremely nasal	0	0
Slightly nasal	3	1
Optimum	41	57
Slightly temporal	56	41
Extremely temporal	0	0

15. Secondary Outcome

Title	Vertical Centration Grade - Lens Fit
Description	Vertical centration graded by -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	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	70
Measure eyes	138	140
Extremely inferior	1	0
Slightly inferior	17	43
Optimum	49	49
Slightly superior	32	9
Extremely superior	0	0

16. Secondary Outcome

Title	Vertical Centration Grade - Lens Fit
Description	Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	66	68
Measure eyes	132	136
Extremely inferior	0	0
Slightly inferior	23	50
Optimum	44	44
Slightly superior	33	6
Extremely superior	0	0

17. Secondary Outcome

Title	Corneal Coverage Grade
Description	Corneal coverage graded by -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	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	70
Measure eyes	138	140
Extremely inadequate	1	0
Slightly inadequate	28	23
Optimum	71	74
Slightly excessive	0	3
Extremely excessive	0	0

18. Secondary Outcome

Title	Corneal Coverage Grade
Description	Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	66	68
Measure eyes	132	136
Extremely inadequate	0	1
Slightly inadequate	36	26
Optimum	64	71
Slightly excessive	0	1
Extremely excessive	0	0

19. Secondary Outcome

Title	Post-Blink Movement Grade
Description	Post-blink movement graded by -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	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	69	70
Measure eyes	138	140
Extremely inadequate	0	0
Slightly inadequate	17	19
Optimum	65	57
Slightly Excessive	16	24
Extremely Excessive	1	0

20. Secondary Outcome

Title	Post-Blink Movement Grade
Description	Post-blink movement graded by -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	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	66	68
Measure eyes	132	136
Extremely inadequate	0	0
Slightly inadequate	21	26
Optimum	67	46
Slightly Excessive	12	26
Extremely Excessive	0	1

21. Secondary Outcome

Title	Ocular Redness Rating
Description	Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Measure Participants	67	68
Mean (Standard Deviation) [units on a scale]	94.1 (8.9)	92.8 (12.7)

Adverse Events

Time Frame	From dispense up to 1 week on each study lens for a total of two weeks.
Arm/Group Title	Somofilcon A		Nelfilcon A
Arm/Group Description	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens		Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
All Cause Mortality
	Somofilcon A		Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Serious Adverse Events
	Somofilcon A		Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A		Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/70 (2.9%)		0/70 (0%)
Eye disorders
Bacterial conjunctivitis	1/70 (1.4%)	1	0/70 (0%)	0
Corneal Abrasion	1/70 (1.4%)	1	0/70 (0%)	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.