Trial Outcomes & Findings for The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses (NCT NCT04067141)

NCT ID: NCT04067141

Last Updated: 2020-11-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline (after 5 minutes of lens dispense)
• Results posted on: 2020-11-24

Participant Flow

Participant milestones

Measure	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens
First Intervention STARTED	35	35
First Intervention COMPLETED	35	34
First Intervention NOT COMPLETED	0	1
Second Intervention STARTED	34	33
Second Intervention COMPLETED	34	31
Second Intervention NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens
First Intervention Withdrawal by Subject	0	1
Second Intervention Adverse Event	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=70 Participants Subjects were randomized to wear somofilcon A 1 day and nelfilcon A for one week in this cross-over study.
Age, Categorical <=18 years	0 Participants n=70 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=70 Participants
Age, Categorical >=65 years	0 Participants n=70 Participants
Age, Continuous	31.6 years STANDARD_DEVIATION 10.0 • n=70 Participants
Sex: Female, Male Female	55 Participants n=70 Participants
Sex: Female, Male Male	15 Participants n=70 Participants
Region of Enrollment United Kingdom	70 participants n=70 Participants

PRIMARY outcome

Timeframe: 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.).

Outcome measures

Measure	Somofilcon A n=69 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=69 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Subjective Comfort at Lens Dispensing	90.9 units on a scale Standard Deviation 11.6	88.5 units on a scale Standard Deviation 12.8

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Subjective Comfort at Start of Day	89.9 units on a scale Standard Deviation 13.8	87.0 units on a scale Standard Deviation 14.7

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Subjective Comfort at End of Day	75.9 units on a scale Standard Deviation 22.1	68.0 units on a scale Standard Deviation 25.5

PRIMARY outcome

Timeframe: 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.).

Outcome measures

Measure	Somofilcon A n=69 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=69 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Overall Subjective Comfort	90.4 units on a scale Standard Deviation 10.1	90.9 units on a scale Standard Deviation 10.8

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Overall Subjective Comfort	86.1 units on a scale Standard Deviation 14.1	78.8 units on a scale Standard Deviation 19.8

PRIMARY outcome

Timeframe: 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.)

Outcome measures

Measure	Somofilcon A n=69 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=69 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Subjective Vision	92.8 units on a scale Standard Deviation 10.1	94.2 units on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Subjective Vision	90.9 units on a scale Standard Deviation 12.1	92.1 units on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: One Week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Biomicroscopy - Conjunctival Redness Score	0.85 units on a scale Standard Deviation 0.25	0.87 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: One week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Biomicroscopy - Limbal Redness Score	0.74 units on a scale Standard Deviation 0.27	0.79 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: One week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Biomicroscopy - Corneal Staining Score	0.33 units on a scale Standard Deviation 0.43	0.32 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: One week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Biomicroscopy - Conjunctival Staining Score	1.46 units on a scale Standard Deviation 0.71	0.35 units on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: One week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Biomicroscopy - Papillary Conjunctivitis Score	1.02 units on a scale Standard Deviation 0.20	1.03 units on a scale Standard Deviation 0.18

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=69 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=70 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Horizontal Centration - Lens Fit Extremely nasal	0 percentage of lenses	0 percentage of lenses
Horizontal Centration - Lens Fit Slightly nasal	6 percentage of lenses	6 percentage of lenses
Horizontal Centration - Lens Fit Optimum	51 percentage of lenses	63 percentage of lenses
Horizontal Centration - Lens Fit Slightly temporal	43 percentage of lenses	31 percentage of lenses
Horizontal Centration - Lens Fit Extremely temporal	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: One Week

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

Outcome measures

Measure	Somofilcon A n=132 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=136 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Horizontal Centration - Lens Fit Extremely nasal	0 percentage of lenses	0 percentage of lenses
Horizontal Centration - Lens Fit Slightly nasal	3 percentage of lenses	1 percentage of lenses
Horizontal Centration - Lens Fit Optimum	41 percentage of lenses	57 percentage of lenses
Horizontal Centration - Lens Fit Slightly temporal	56 percentage of lenses	41 percentage of lenses
Horizontal Centration - Lens Fit Extremely temporal	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=138 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=140 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Vertical Centration Grade - Lens Fit Extremely inferior	1 percentage of lenses	0 percentage of lenses
Vertical Centration Grade - Lens Fit Slightly inferior	17 percentage of lenses	43 percentage of lenses
Vertical Centration Grade - Lens Fit Optimum	49 percentage of lenses	49 percentage of lenses
Vertical Centration Grade - Lens Fit Slightly superior	32 percentage of lenses	9 percentage of lenses
Vertical Centration Grade - Lens Fit Extremely superior	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: One week

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

Outcome measures

Measure	Somofilcon A n=132 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=136 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Vertical Centration Grade - Lens Fit Extremely inferior	0 percentage of lenses	0 percentage of lenses
Vertical Centration Grade - Lens Fit Slightly inferior	23 percentage of lenses	50 percentage of lenses
Vertical Centration Grade - Lens Fit Optimum	44 percentage of lenses	44 percentage of lenses
Vertical Centration Grade - Lens Fit Slightly superior	33 percentage of lenses	6 percentage of lenses
Vertical Centration Grade - Lens Fit Extremely superior	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=138 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=140 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Corneal Coverage Grade Extremely inadequate	1 percentage of lenses	0 percentage of lenses
Corneal Coverage Grade Slightly inadequate	28 percentage of lenses	23 percentage of lenses
Corneal Coverage Grade Optimum	71 percentage of lenses	74 percentage of lenses
Corneal Coverage Grade Slightly excessive	0 percentage of lenses	3 percentage of lenses
Corneal Coverage Grade Extremely excessive	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=132 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=136 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Corneal Coverage Grade Extremely inadequate	0 percentage of lenses	1 percentage of lenses
Corneal Coverage Grade Slightly inadequate	36 percentage of lenses	26 percentage of lenses
Corneal Coverage Grade Optimum	64 percentage of lenses	71 percentage of lenses
Corneal Coverage Grade Slightly excessive	0 percentage of lenses	1 percentage of lenses
Corneal Coverage Grade Extremely excessive	0 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=138 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=140 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Post-Blink Movement Grade Extremely inadequate	0 percentage of lenses	0 percentage of lenses
Post-Blink Movement Grade Slightly inadequate	17 percentage of lenses	19 percentage of lenses
Post-Blink Movement Grade Optimum	65 percentage of lenses	57 percentage of lenses
Post-Blink Movement Grade Slightly Excessive	16 percentage of lenses	24 percentage of lenses
Post-Blink Movement Grade Extremely Excessive	1 percentage of lenses	0 percentage of lenses

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Somofilcon A n=132 eyes Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=136 eyes Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Post-Blink Movement Grade Extremely inadequate	0 percentage of lenses	0 percentage of lenses
Post-Blink Movement Grade Slightly inadequate	21 percentage of lenses	26 percentage of lenses
Post-Blink Movement Grade Optimum	67 percentage of lenses	46 percentage of lenses
Post-Blink Movement Grade Slightly Excessive	12 percentage of lenses	26 percentage of lenses
Post-Blink Movement Grade Extremely Excessive	0 percentage of lenses	1 percentage of lenses

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Somofilcon A n=67 Participants Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=68 Participants Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Ocular Redness Rating	94.1 units on a scale Standard Deviation 8.9	92.8 units on a scale Standard Deviation 12.7

Adverse Events

Somofilcon A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nelfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Somofilcon A n=70 participants at risk Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens	Nelfilcon A n=70 participants at risk Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens
Eye disorders Bacterial conjunctivitis	1.4% 1/70 • Number of events 1 • From dispense up to 1 week on each study lens for a total of two weeks.	0.00% 0/70 • From dispense up to 1 week on each study lens for a total of two weeks.
Eye disorders Corneal Abrasion	1.4% 1/70 • Number of events 1 • From dispense up to 1 week on each study lens for a total of two weeks.	0.00% 0/70 • From dispense up to 1 week on each study lens for a total of two weeks.

Additional Information

Jose A. Vega, O.D., MSC., FAAO

CooperVision, Inc.

Phone: 9256213761

Email: javega@coopervision.com

Results disclosure agreements

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