Trial Outcomes & Findings for Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers (NCT NCT03871543)

NCT ID: NCT03871543

Last Updated: 2023-05-16

Results Overview

Lid margin staining of the upper and lower eyelids was performed in the left eye (OS) only using lissamine green. The following attributes were graded subjectively for each eyelid: Horizontal length of staining (Grade 0: \< 2mm, Grade 1: 2-4 mm, Grade 2: 5-9 mm, Grade 3: \>9 mm), and Sagittal width of staining relative to width of wiper (Grade 0: \<25%, Grade 1: 25-50 %, Grade 2: 51-75%, Grade 3: \>75%). The Average staining grade for each eyelid was also calculated which is the average of the horizontal and sagittal grades. Higher Lid Margin Staining values indicate that more staining was observed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 196 participants
• Primary outcome timeframe: 14 Hours Follow-up at Visit 4
• Results posted on: 2023-05-16

Participant Flow

A total of 196 subjects were enrolled into this study. Of those enrolled, 184 subjects were dispensed at least one study lens while, 12 subjects failed to meet all eligibility criteria. Of those dispensed, 46 completed the study and 138 subjects were discontinued.

Participant milestones

Measure	Test 1 (Dailies Aqua Comfort Plus) \ Test 2 (Acuvue Oasys 1-Day) All eligible subjects in this study were first the dispensed Test 1 (Dailies Aqua Comfort Plus) lens during the first period and the Test 2 (Acuvue Oasys 1-Day) lens during the second period
Period 1 STARTED	184
Period 1 COMPLETED	48
Period 1 NOT COMPLETED	136
Period 2 STARTED	48
Period 2 COMPLETED	46
Period 2 NOT COMPLETED	2

Reasons for withdrawal

Measure	Test 1 (Dailies Aqua Comfort Plus) \ Test 2 (Acuvue Oasys 1-Day) All eligible subjects in this study were first the dispensed Test 1 (Dailies Aqua Comfort Plus) lens during the first period and the Test 2 (Acuvue Oasys 1-Day) lens during the second period
Period 1 Unsatisfactory Lens Fitting due Test Article	10
Period 1 Investigator Error	1
Period 1 Protocol Violation	2
Period 1 COVID-19 Related	1
Period 1 Subject No Longer meets Eligibility Criteria	112
Period 1 Withdrawal by Subject	10
Period 2 Adverse Event	1
Period 2 Withdrawal by Subject	1

Baseline Characteristics

Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

Baseline characteristics by cohort

Measure	Asymptomatic n=88 Participants Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=20 Participants Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.	Other n=58 Participants Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score between 11-19 after 2-week wears of lens wear.	Unknown n=18 Participants Subjects with Unknown Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score	Total n=184 Participants Total of all reporting groups
Age, Continuous	28 Years STANDARD_DEVIATION 6.67 • n=5 Participants	27.8 Years STANDARD_DEVIATION 7.09 • n=7 Participants	25.1 Years STANDARD_DEVIATION 6.32 • n=5 Participants	28.1 Years STANDARD_DEVIATION 8.83 • n=4 Participants	27.1 Years STANDARD_DEVIATION 6.92 • n=21 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	16 Participants n=7 Participants	45 Participants n=5 Participants	11 Participants n=4 Participants	134 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants	7 Participants n=4 Participants	50 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants	8 Participants n=4 Participants	45 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants	10 Participants n=4 Participants	119 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Lid margin staining of the upper and lower eyelids was performed in the left eye (OS) only using lissamine green. The following attributes were graded subjectively for each eyelid: Horizontal length of staining (Grade 0: < 2mm, Grade 1: 2-4 mm, Grade 2: 5-9 mm, Grade 3: >9 mm), and Sagittal width of staining relative to width of wiper (Grade 0: <25%, Grade 1: 25-50 %, Grade 2: 51-75%, Grade 3: >75%). The Average staining grade for each eyelid was also calculated which is the average of the horizontal and sagittal grades. Higher Lid Margin Staining values indicate that more staining was observed.

Outcome measures

Measure	Asymptomatic n=28 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=18 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) Upper Lid	1.02 Units on a Scale Standard Deviation 0.822	1.25 Units on a Scale Standard Deviation 0.943
Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) Lower Lid	1.45 Units on a Scale Standard Deviation 0.896	1.78 Units on a Scale Standard Deviation 0.988

PRIMARY outcome

Timeframe: 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

NIBUT was measured in timed seconds using the Medmont topographer for the right eye (OD) only. NIBUT values are positive, where higher NIBUT times (seconds) indicate a more stable tear film.

Outcome measures

Measure	Asymptomatic n=28 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=18 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)	4.43 Seconds Standard Deviation 3.386	4.32 Seconds Standard Deviation 3.613

PRIMARY outcome

Timeframe: 14 Hours Follow-up at Visit-4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

The lower tear meniscus in the right eye (OD) only was imaged and measured in mm using optical coherence tomography (OCT). Lower TMH values indicate reduced tear quantity.

Outcome measures

Measure	Asymptomatic n=28 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=18 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)	0.20 mm Standard Deviation 0.058	0.19 mm Standard Deviation 0.069

PRIMARY outcome

Timeframe: 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Tear film osmolarity were collected and measured in (mOsms/L) in the right eye (OD) only using the Tearlab (Tearlab Corp.).Higher tear osmolarity values may be associated with ocular dryness. Participants were classified as symptomatic or asymptomatic based on their subjective questionnaire responses for the CLDEQ-8 questionnaire assessed after two weeks of lens wear (Visit 2). CLDEQ-8 is a validated patient-reported outcome measure assessing patient-experience of symptoms relating to contact lens dryness.

Outcome measures

Measure	Asymptomatic n=28 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=18 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)	299.00 mOsms/L Standard Deviation 12.098	301.89 mOsms/L Standard Deviation 12.107

PRIMARY outcome

Timeframe: 2-Week Follow-up (after 6 hours lens wear) at Visit 2

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Images, using Confocal Microscopy were taken in both eyes for both the upper and lower eyelid in the central lid area. These images were used to determine the mean density of inflammatory white blood cells. Higher white blood cell counts may be associated with an increased inflammatory response. The number of white blood cells is a count of the number of cells 'per frame'. A frame has a fixed area of 400 x 400 microns. The average number of White Blood Cells was reported for each group.

Outcome measures

Measure	Asymptomatic n=56 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic n=34 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) Upper Lid	7.94 number of white blood cells per frame Standard Deviation 8.450	14.91 number of white blood cells per frame Standard Deviation 12.562
Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) Lower	5.89 number of white blood cells per frame Standard Deviation 6.184	12.19 number of white blood cells per frame Standard Deviation 12.210

SECONDARY outcome

Timeframe: VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)	76.24 Units on a Scale Standard Deviation 23.999	—

SECONDARY outcome

Timeframe: VAS, and TMH 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)	76.24 Units on a Scale Standard Deviation 23.999	—

SECONDARY outcome

Timeframe: VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)	76.24 Units on a Scale Standard Deviation 23.999	—

SECONDARY outcome

Timeframe: VAS, and NIBUT 14 Hours Follow-up at Visit 4

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4, (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)	76.24 Units on a Scale Standard Deviation 23.999	—

SECONDARY outcome

Timeframe: VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus)	67.05 Units on a Scale Standard Deviation 30.322	—

SECONDARY outcome

Timeframe: VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus)	67.05 Units on a Scale Standard Deviation 30.322	—

SECONDARY outcome

Timeframe: VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day)	85.28 Units on a Scale Standard Deviation 18.439	—

SECONDARY outcome

Timeframe: VAS, and TMH 14 Hours Follow-up at Visit 8

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day)	85.28 Units on a Scale Standard Deviation 18.439	—

SECONDARY outcome

Timeframe: VAS, and LMS 14 Hours Follow-up at Visit 8

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day)	85.28 Units on a Scale Standard Deviation 18.439	—

SECONDARY outcome

Timeframe: VAS, and LMS 14 Hours Follow-up at Visit 8

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day)	85.28 Units on a Scale Standard Deviation 18.439	—

SECONDARY outcome

Timeframe: VAS, and WBC before lens removal at Visit 6

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day)	85.53 Units on a Scale Standard Deviation 20.803	—

SECONDARY outcome

Timeframe: VAS, and WBC before lens removal at Visit 6

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8, (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day).

Outcome measures

Measure	Asymptomatic n=92 Eyes Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score less than or equal to 10 after 2-week wears of lens wear.	Symptomatic Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score greater than or equal to 20 after 2-week wears of lens wear.
Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day)	85.53 Units on a Scale Standard Deviation 20.803	—

Adverse Events

Test 1 (Dailies Aqua Comfort Plus)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test 2 (Acuvue Oasys 1-Day)

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

Ross Franklin

Johnson & Johnson Vision Care, Inc.

Phone: 1 800-843-2020

Email: RFRANKL1@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60