Trial Outcomes & Findings for Clinical Evaluation of Stenfilcon A Contact Lenses (NCT NCT03471832)

NCT ID: NCT03471832

Last Updated: 2020-01-29

Results Overview

Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 5 minutes
• Results posted on: 2020-01-29

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Stenfilcon A Lens Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Overall Study STARTED	40 40	40 40
Overall Study COMPLETED	40 40	40 40
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=40 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants
Age, Continuous	31 years STANDARD_DEVIATION 10 • n=40 Participants
Sex: Female, Male Female	34 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=40 Participants
Region of Enrollment Japan	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 5 minutes

Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Lens Movement Tight	0 Number of eyes	0 Number of eyes
Lens Movement Slightly tight	0 Number of eyes	3 Number of eyes
Lens Movement Optimum	30 Number of eyes	30 Number of eyes
Lens Movement Slightly Loose	10 Number of eyes	7 Number of eyes
Lens Movement Loose	0 Number of eyes	0 Number of eyes

PRIMARY outcome

Timeframe: 3hrs

Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Lens Movement Tight	0 Number of eyes	0 Number of eyes
Lens Movement Slightly tight	5 Number of eyes	11 Number of eyes
Lens Movement Optimum	32 Number of eyes	26 Number of eyes
Lens Movement Slightly Loose	3 Number of eyes	3 Number of eyes
Lens Movement Loose	0 Number of eyes	0 Number of eyes

PRIMARY outcome

Timeframe: 5 minutes

Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Horizontal Lens Centration Temporal	0 Number of eyes	0 Number of eyes
Horizontal Lens Centration Slightly temporal	4 Number of eyes	8 Number of eyes
Horizontal Lens Centration Center	36 Number of eyes	32 Number of eyes
Horizontal Lens Centration Slightly nasal	0 Number of eyes	0 Number of eyes
Horizontal Lens Centration Nasal	0 Number of eyes	0 Number of eyes

PRIMARY outcome

Timeframe: 3hrs

Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Horizontal Lens Centration Center	39 number of eyes	32 number of eyes
Horizontal Lens Centration Slightly nasal	0 number of eyes	0 number of eyes
Horizontal Lens Centration Nasal	0 number of eyes	0 number of eyes
Horizontal Lens Centration Temporal	0 number of eyes	0 number of eyes
Horizontal Lens Centration Slightly temporal	1 number of eyes	8 number of eyes

PRIMARY outcome

Timeframe: 5 minutes

Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Vertical Lens Centration Superior	0 Number of eyes	0 Number of eyes
Vertical Lens Centration Slightly superior	3 Number of eyes	10 Number of eyes
Vertical Lens Centration Center	35 Number of eyes	27 Number of eyes
Vertical Lens Centration Slightly inferior	2 Number of eyes	3 Number of eyes
Vertical Lens Centration Inferior	0 Number of eyes	0 Number of eyes

PRIMARY outcome

Timeframe: 3hrs

Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Vertical Lens Centration Superior	0 Count of eyes	0 Count of eyes
Vertical Lens Centration Slightly superior	1 Count of eyes	6 Count of eyes
Vertical Lens Centration Center	39 Count of eyes	28 Count of eyes
Vertical Lens Centration Slightly inferior	0 Count of eyes	6 Count of eyes
Vertical Lens Centration Inferior	0 Count of eyes	0 Count of eyes

PRIMARY outcome

Timeframe: 5 minutes

Does lens cover the cornea: (Yes, No)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Corneal Coverage Yes	40 number of eyes	40 number of eyes
Corneal Coverage No	0 number of eyes	0 number of eyes

PRIMARY outcome

Timeframe: 3hrs

Does lens cover the cornea: (Yes, No)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Corneal Coverage Yes	40 number of eyes	40 number of eyes
Corneal Coverage No	0 number of eyes	0 number of eyes

PRIMARY outcome

Timeframe: 5 minutes

Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Lens Lag Move along with cornea	35 number of eyes	34 number of eyes
Lens Lag Slightly Delay	3 number of eyes	5 number of eyes
Lens Lag Delay	2 number of eyes	1 number of eyes

PRIMARY outcome

Timeframe: 3hrs

Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Lens Lag Move along with cornea	39 number of eyes	36 number of eyes
Lens Lag Slightly Delay	1 number of eyes	4 number of eyes
Lens Lag Delay	0 number of eyes	0 number of eyes

PRIMARY outcome

Timeframe: 5 minutes

Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Overall Fitting Performance Optimum	30 number of eyes	25 number of eyes
Overall Fitting Performance Good	8 number of eyes	11 number of eyes
Overall Fitting Performance Acceptable	2 number of eyes	4 number of eyes
Overall Fitting Performance Unacceptable	0 number of eyes	0 number of eyes

PRIMARY outcome

Timeframe: 3hrs

Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Overall Fitting Performance Good	6 number of eyes	14 number of eyes
Overall Fitting Performance Optimum	32 number of eyes	22 number of eyes
Overall Fitting Performance Acceptable	2 number of eyes	4 number of eyes
Overall Fitting Performance Unacceptable	0 number of eyes	0 number of eyes

PRIMARY outcome

Timeframe: 5 minutes

Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

Outcome measures

Measure	Stenfilcon A Lens n=40 Participants Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Investigator Fit Preference Either	24 Participants	—
Investigator Fit Preference Prefer stenfilcon A strongly	5 Participants	—
Investigator Fit Preference Prefer stenfilcon A slightly	6 Participants	—
Investigator Fit Preference Prefer narafilcon A slightly	4 Participants	—
Investigator Fit Preference Prefer narafilcon A strongly	1 Participants	—

PRIMARY outcome

Timeframe: 3hrs

Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

Outcome measures

Measure	Stenfilcon A Lens n=40 Participants Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Investigator Fit Preference Prefer stenfilcon A slightly	12 Participants	—
Investigator Fit Preference Either	17 Participants	—
Investigator Fit Preference Prefer narafilcon A slightly	6 Participants	—
Investigator Fit Preference Prefer narafilcon A strongly	0 Participants	—
Investigator Fit Preference Prefer stenfilcon A strongly	5 Participants	—

SECONDARY outcome

Timeframe: Baseline

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Comfort	8.1 units on a scale Standard Deviation 2.0	8.1 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 5 Minutes

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Comfort	8.2 units on a scale Standard Deviation 2.2	8.2 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 3 hours

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Comfort	8.2 units on a scale Standard Deviation 2.3	8.4 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Dryness	9.3 units on a scale Standard Deviation 1.2	8.1 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 5 minutes

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Dryness	9.1 units on a scale Standard Deviation 1.5	8.2 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 3 hours

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Dryness	8.5 units on a scale Standard Deviation 1.9	8.4 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Stinging/Burning	9.5 units on a scale Standard Deviation 1.2	8.8 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 5 minutes

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Stinging/Burning	9.8 units on a scale Standard Deviation 0.7	9.0 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 3 hours

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Stinging/Burning	9.6 units on a scale Standard Deviation 1.0	9.6 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Edge/Lens Awareness	9.0 units on a scale Standard Deviation 2.0	9.4 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 5 minutes

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Edge/Lens Awareness	8.9 units on a scale Standard Deviation 1.9	9.1 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 3 hours

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Outcome measures

Measure	Stenfilcon A Lens n=40 Eyes Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens n=40 Eyes Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Edge/Lens Awareness	8.7 units on a scale Standard Deviation 2.4	9.2 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Outcome measures

Measure	Stenfilcon A Lens n=39 Participants Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Subjective Lens Preference Prefer stenfilcon A	14 Participants	—
Subjective Lens Preference Either	13 Participants	—
Subjective Lens Preference Neither	1 Participants	—
Subjective Lens Preference Prefer narafilcon A	11 Participants	—

SECONDARY outcome

Timeframe: 5 minutes

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Outcome measures

Measure	Stenfilcon A Lens n=39 Participants Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Subjective Lens Preference Prefer stenfilcon A	13 Participants	—
Subjective Lens Preference Either	14 Participants	—
Subjective Lens Preference Neither	2 Participants	—
Subjective Lens Preference Prefer narafilcon A	10 Participants	—

SECONDARY outcome

Timeframe: 3 hours

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Outcome measures

Measure	Stenfilcon A Lens n=39 Participants Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens	Narafilcon A Lens Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens
Subjective Lens Preference Either	18 Participants	—
Subjective Lens Preference Neither	1 Participants	—
Subjective Lens Preference Prefer narafilcon A	9 Participants	—
Subjective Lens Preference Prefer stenfilcon A	12 Participants	—

Adverse Events

Stenfilcon A Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon A 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

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

CooperVision

Phone: 9256213761

Email: javega@coopervision.com

Results disclosure agreements

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