Trial Outcomes & Findings for Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens (NCT NCT03372551)

NCT ID: NCT03372551

Last Updated: 2019-07-23

Results Overview

Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: up to 1 week
• Results posted on: 2019-07-23

Participant Flow

Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.

Participant milestones

Measure	Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
First Intervention (1 Week) STARTED	17	16
First Intervention (1 Week) COMPLETED	16	16
First Intervention (1 Week) NOT COMPLETED	1	0
Second Intervention (1 Week) STARTED	16	16
Second Intervention (1 Week) COMPLETED	16	16
Second Intervention (1 Week) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
First Intervention (1 Week) Withdrawal by Subject	1	0

Baseline Characteristics

Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

Baseline characteristics by cohort

Measure	Somofilcon A 1 Day Test vs Control Contact Lens n=32 Participants Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair. somofilcon A 1 day test lens: Test / Contact lens somofilcon A 1 day control lens: Test / Contact lens
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants
Region of Enrollment Canada	32 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 week

Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=32 Participants Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens n=32 Participants Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Comfort Comfort at Dispense	90 score on a scale Standard Deviation 8	89 score on a scale Standard Deviation 11	—	—
Comfort Comfort at Insertion after 1 week	86 score on a scale Standard Deviation 11	87 score on a scale Standard Deviation 16	—	—
Comfort Comfort during day after 1 week	84 score on a scale Standard Deviation 11	86 score on a scale Standard Deviation 11	—	—
Comfort Comfort end day after 1 week	75 score on a scale Standard Deviation 15	78 score on a scale Standard Deviation 16	—	—
Comfort Overall comfort after 1 week of lens wear	82 score on a scale Standard Deviation 11	85 score on a scale Standard Deviation 12	—	—

PRIMARY outcome

Timeframe: up to 1 week

Overall lens that subject prefers or no preference

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=32 Participants Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Preference Strongly preferred somofilcon A 1 Day Test lens	5 Participants	—	—	—
Preference Slightly preferred somofilcon A 1 Day Test lens	9 Participants	—	—	—
Preference No preference	1 Participants	—	—	—
Preference Slightly preferred somofilcon A 1 Day Control lens	5 Participants	—	—	—
Preference Strongly preferred somofilcon A 1 Day control lens	12 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 1 week

Population: Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.

Visual acuity measured in logMAR

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=32 Participants Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens n=31 Participants Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense n=32 Participants Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week n=31 Participants Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Vision High Illumination high contrast monocular	-0.10 Log(MAR) Standard Deviation 0.07	-0.10 Log(MAR) Standard Deviation 0.07	-0.11 Log(MAR) Standard Deviation 0.07	-0.11 Log(MAR) Standard Deviation 0.06
Vision High Illumination high contrast binocular	-0.15 Log(MAR) Standard Deviation 0.06	-0.15 Log(MAR) Standard Deviation 0.07	-0.15 Log(MAR) Standard Deviation 0.06	-0.16 Log(MAR) Standard Deviation 0.06
Vision Low Illumination high contrast monocular	-0.08 Log(MAR) Standard Deviation 0.05	-0.07 Log(MAR) Standard Deviation 0.07	-0.09 Log(MAR) Standard Deviation 0.07	-0.10 Log(MAR) Standard Deviation 0.06
Vision Low Illumination high contrast binocular	-0.13 Log(MAR) Standard Deviation 0.06	-0.13 Log(MAR) Standard Deviation 0.07	-0.13 Log(MAR) Standard Deviation 0.06	-0.14 Log(MAR) Standard Deviation 0.05

PRIMARY outcome

Timeframe: up to 1 week

Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=32 Participants Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens n=32 Participants Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Subjective Vision Dispense	92 score on a scale Standard Deviation 9	92 score on a scale Standard Deviation 6	—	—
Subjective Vision 1 week	88 score on a scale Standard Deviation 12	91 score on a scale Standard Deviation 11	—	—

PRIMARY outcome

Timeframe: up to 1 week

Population: Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.

Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=64 Eye Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens n=64 Eye Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Corneal Staining Baseline	0.16 score on a scale Standard Deviation 0.25	0.16 score on a scale Standard Deviation 0.25	—	—
Corneal Staining 1 week	0.20 score on a scale Standard Deviation 0.26	0.18 score on a scale Standard Deviation 0.42	—	—

PRIMARY outcome

Timeframe: up to 1 week

Population: Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.

Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps

Outcome measures

Measure	Somofilcon A 1 Day Test Lens n=64 Eyes Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens n=64 Eyes Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens Dispense Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Somofilcon A 1 Day Control Lens 1 Week Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Conjunctival Staining Baseline	0.20 score on a scale Standard Deviation 0.25	0.20 score on a scale Standard Deviation 0.25	—	—
Conjunctival Staining 1 week	0.72 score on a scale Standard Deviation 0.57	0.91 score on a scale Standard Deviation 0.71	—	—

Adverse Events

Somofilcon A 1 Day Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Somofilcon A 1 Day Control Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myhanh Nguyen, Sr. Optometrist

Coopervision

Phone: 925-730-6716

Email: mnguyen@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
• Publication restrictions are in place

Restriction type: OTHER