Trial Outcomes & Findings for Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers (NCT NCT01494545)

NCT ID: NCT01494545

Last Updated: 2013-07-19

Results Overview

Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2013-07-19

Participant Flow

Participants were recruited from study centers in Europe.

This reporting group includes all enrolled participants.

Participant milestones

Measure	Delefilcon A Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Overall Study STARTED	102
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

Baseline characteristics by cohort

Measure	Delefilcon A n=98 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Age Continuous	24.8 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Initial Comfort	8.6 Units on a scale Standard Deviation 1.3	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Comfort at Insertion by Visit Day 7	8.6 Units on a scale Standard Deviation 1.3	—	—
Comfort at Insertion by Visit Day 14	8.8 Units on a scale Standard Deviation 1.2	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Comfort During the Day by Visit Day 7	8.7 Units on a scale Standard Deviation 1.3	—	—
Comfort During the Day by Visit Day 14	8.9 Units on a scale Standard Deviation 1.0	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Comfort at End of Day by Visit Day 7	7.5 Units on a scale Standard Deviation 1.8	—	—
Comfort at End of Day by Visit Day 14	7.9 Units on a scale Standard Deviation 1.5	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Overall Comfort by Visit Day 7	8.5 Units on a scale Standard Deviation 1.2	—	—
Overall Comfort by Visit Day 14	8.7 Units on a scale Standard Deviation 1.0	—	—

PRIMARY outcome

Timeframe: Day 1

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Initial Quality of Vision	8.7 Units on a scale Standard Deviation 1.1	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Quality of Vision at Insertion by Visit Day 7	8.7 Units on a scale Standard Deviation 1.2	—	—
Quality of Vision at Insertion by Visit Day 14	9.0 Units on a scale Standard Deviation 1.2	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Quality of Vision During the Day by Visit Day 7	8.9 Units on a scale Standard Deviation 1.2	—	—
Quality of Vision During the Day by Visit Day 14	8.9 Units on a scale Standard Deviation 1.1	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Quality of Vision at End of Day by Visit Day 7	8.3 Units on a scale Standard Deviation 1.5	—	—
Quality of Vision at End of Day by Visit Day 14	8.3 Units on a scale Standard Deviation 1.4	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Overall Quality of Vision by Visit Day 7	8.8 Units on a scale Standard Deviation 1.1	—	—
Overall Quality of Vision by Visit Day 14	8.8 Units on a scale Standard Deviation 1.1	—	—

PRIMARY outcome

Timeframe: Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Average Comfortable Daily Wear Time by Visit Day 7	10.3 Hours Standard Deviation 3.2	—	—
Average Comfortable Daily Wear Time by Visit Day 14	10.4 Hours Standard Deviation 2.8	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything. Strongly Agree	17.4 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything. Agree	43.5 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything. Disagree	37.0 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything. Strongly Disagree	2.2 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything. Strongly Agree	19.8 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything. Agree	68.1 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything. Disagree	12.1 Percentage of participants	—	—
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything. Strongly Disagree	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them. Strongly Agree	18.5 Percentage of participants	—	—
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them. Agree	45.7 Percentage of participants	—	—
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them. Disagree	33.7 Percentage of participants	—	—
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them. Strongly Disagree	2.2 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses. Strongly Agree	45.7 Percentage of participants	—	—
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses. Agree	47.8 Percentage of participants	—	—
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses. Disagree	5.4 Percentage of participants	—	—
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses. Strongly Disagree	1.1 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends. Strongly Agree	41.3 Percentage of participants	—	—
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends. Agree	54.3 Percentage of participants	—	—
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends. Disagree	4.3 Percentage of participants	—	—
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends. Strongly Disagree	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses. Strongly Agree	22.8 Percentage of participants	—	—
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses. Agree	44.6 Percentage of participants	—	—
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses. Disagree	30.4 Percentage of participants	—	—
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses. Strongly Disagree	2.2 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses. Strongly Agree	9.8 Percentage of participants	—	—
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses. Agree	35.9 Percentage of participants	—	—
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses. Disagree	50.0 Percentage of participants	—	—
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses. Strongly Disagree	4.3 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses. Strongly Agree	46.7 Percentage of participants	—	—
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses. Agree	45.7 Percentage of participants	—	—
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses. Disagree	7.6 Percentage of participants	—	—
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses. Strongly Disagree	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: Much Better	21.7 Percentage of participants	—	—
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: A Little Better	41.3 Percentage of participants	—	—
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: Same	22.8 Percentage of participants	—	—
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: A Little Worse	14.1 Percentage of participants	—	—
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: Much Worse	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Likert Statement: I am Interested in Purchasing These Contact Lenses. Very Interested	28.3 Percentage of participants	—	—
Likert Statement: I am Interested in Purchasing These Contact Lenses. Interested	64.1 Percentage of participants	—	—
Likert Statement: I am Interested in Purchasing These Contact Lenses. Not Interested	7.6 Percentage of participants	—	—
Likert Statement: I am Interested in Purchasing These Contact Lenses. Very Disinterested	0.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 1

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

Outcome measures

Measure	Delefilcon A n=92 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye n=92 eyes Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes n=184 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Lens Surface Characteristics: Dry Areas/Non-wetting None	85.9 Percentage of eyes	81.5 Percentage of eyes	83.7 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-wetting Very Slight	13.0 Percentage of eyes	15.2 Percentage of eyes	14.1 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-wetting Slight	1.1 Percentage of eyes	3.3 Percentage of eyes	2.2 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-wetting Moderate	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-wetting Severe	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes

SECONDARY outcome

Timeframe: Day 7

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

Outcome measures

Measure	Delefilcon A n=92 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye n=92 eyes Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes n=184 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Lens Surface Characteristics: Dry Areas/Non-Wetting None	81.1 Percentage of eyes	82.2 Percentage of eyes	81.7 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Very Slight	15.6 Percentage of eyes	15.6 Percentage of eyes	15.6 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Slight	3.3 Percentage of eyes	2.2 Percentage of eyes	2.8 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Moderate	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Severe	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes

SECONDARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

Outcome measures

Measure	Delefilcon A n=92 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye n=92 eyes Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes n=184 eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Lens Surface Characteristics: Dry Areas/Non-Wetting None	77.2 Percentage of eyes	76.1 Percentage of eyes	76.6 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Very Slight	19.6 Percentage of eyes	23.9 Percentage of eyes	21.7 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Slight	3.3 Percentage of eyes	0.0 Percentage of eyes	1.6 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Moderate	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes
Lens Surface Characteristics: Dry Areas/Non-Wetting Severe	0.0 Percentage of eyes	0.0 Percentage of eyes	0.0 Percentage of eyes

SECONDARY outcome

Timeframe: Day 1

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Duration of Overall Training Time Insertion time	6.926 Minutes Standard Deviation 6.558	—	—
Duration of Overall Training Time Removal time	6.806 Minutes Standard Deviation 7.872	—	—

SECONDARY outcome

Timeframe: Day 1, Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Investigator's Satisfaction With Lens Fit by Visit Day 1	9.2 Units on a scale Standard Deviation 0.9	—	—
Investigator's Satisfaction With Lens Fit by Visit Day 7	9.3 Units on a scale Standard Deviation 0.9	—	—
Investigator's Satisfaction With Lens Fit by Visit Day 14	9.3 Units on a scale Standard Deviation 0.8	—	—

SECONDARY outcome

Timeframe: Day 1, Day 7, Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Investigator's Overall Impression of Surface Wettability by Visit Day 1	9.3 Units on a scale Standard Deviation 0.9	—	—
Investigator's Overall Impression of Surface Wettability by Visit Day 7	9.3 Units on a scale Standard Deviation 1.0	—	—
Investigator's Overall Impression of Surface Wettability by Visit Day 14	9.3 Units on a scale Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: Day 14

Population: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

The investigator indicated agreement/disagreement with the statement, "The study lenses were easy to fit for this subject," by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree.

Outcome measures

Measure	Delefilcon A n=92 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.	Delefilcon A, Left Eye Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.	Delefilcon A, Both Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Investigator's Rating of Ease of Fit Strongly Agree	75.0 Percentage of participants	—	—
Investigator's Rating of Ease of Fit Agree	22.8 Percentage of participants	—	—
Investigator's Rating of Ease of Fit Disagree	2.2 Percentage of participants	—	—
Investigator's Rating of Ease of Fit Strongly Disagree	0.0 Percentage of participants	—	—

Adverse Events

Delefilcon 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

Adverse event data not reported

Additional Information

Jami Kern, PhD

Alcon Research, Ltd

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER