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This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Other | All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1 |
|
| Part 2 | Other | All eligible subjects (based on CLDEQ responses) enrolled into Part 2 will be fit and dispensed with Test Lens 2 and will follow the same procedures as Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AquaComfort Plus | Device | Test Lens 1 |
| |
| Acuvue Oasys 1-Day |
| Measure | Description | Time Frame |
|---|---|---|
| Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | 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. | 14 Hours Follow-up at Visit 4 |
| Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | 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. | 14 Hours Follow-up at Visit 4 |
| Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | 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. | 14 Hours Follow-up at Visit-4 |
| Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | 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. | 14 Hours Follow-up at Visit 4 |
| Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | 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). |
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Inclusion Criteria:
Potential subjects must satisfy all of the criteria listed to be enrolled in the study.
They are 18-45 years of age (inclusive).
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research while enrolled on this study.
They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
They agree to wear their lenses for at least 12-14 hours per day.
They own a wearable pair of spectacles (by self-report).
They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
They have best corrected distance visual acuity of at least 0.20 binocularly
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester - Eurolens Research | Manchester | United Kingdom |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||||||||
| Period 2 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Asymptomatic | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | 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. | 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. | Posted | Mean | Standard Deviation | Units on a Scale | 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
|
Throughout the duration of the study; The average completion time was 171 days per subject. The minimum completion time was 57 days, and the maximum was 576 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test 1 (Dailies Aqua Comfort Plus) | Subjects wore the Test 1 [Dailies Aqua Comfort Plus] lens during period 1 of the study |
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Participants were classified as symptomatic or asymptomatic based on their responses to the CLDEQ-8 questionnaire after 2-weeks of lens wear. CLDEQ is a validated questionnaire assessing patient experience of symptoms related to contact lens dryness. Total Scores were calculated by summing subjects' responses to individual items (Chalmers et al, Contact Lens & Anterior Eye 2016, 342-352). Total scores range from 0 to 37 where higher scores indicate more dryness related to contact lens wear.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin | Johnson & Johnson Vision Care, Inc. | 1 800-843-2020 | RFRANKL1@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2020 | Feb 2, 2023 | Prot_SAP_000.pdf |
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| Device |
Test Lens 2 |
|
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. |
| 2-Week Follow-up (after 6 hours lens wear) at Visit 2 |
| VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4 |
| Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | 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). | VAS, and TMH 14 Hours Follow-up at Visit 4 |
| Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | 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). | VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4 |
| Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | 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). | VAS, and NIBUT 14 Hours Follow-up at Visit 4 |
| Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus) | 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). | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 |
| Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus) | 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). | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 |
| Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8 |
| Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and TMH 14 Hours Follow-up at Visit 8 |
| Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and LMS 14 Hours Follow-up at Visit 8 |
| Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and LMS 14 Hours Follow-up at Visit 8 |
| Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and WBC before lens removal at Visit 6 |
| Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day) | 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). | VAS, and WBC before lens removal at Visit 6 |
| COVID-19 Related |
|
| Subject No Longer meets Eligibility Criteria |
|
| Withdrawal by Subject |
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| BG002 | Other | Subjects with a Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score between 11-19 after 2-week wears of lens wear. |
| BG003 | Unknown | Subjects with Unknown Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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. |
| OG001 | 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. |
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| Primary | Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | 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. | 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. | Posted | Mean | Standard Deviation | Seconds | 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Primary | Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | 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. | 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. | Posted | Mean | Standard Deviation | mm | 14 Hours Follow-up at Visit-4 | Eyes | Eyes |
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| Primary | Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | 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. | 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. | Posted | Mean | Standard Deviation | mOsms/L | 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Primary | Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) | 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. | 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. | Posted | Mean | Standard Deviation | number of white blood cells per frame | 2-Week Follow-up (after 6 hours lens wear) at Visit 2 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and TMH 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and NIBUT 14 Hours Follow-up at Visit 4 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and TMH 14 Hours Follow-up at Visit 8 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and LMS 14 Hours Follow-up at Visit 8 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and LMS 14 Hours Follow-up at Visit 8 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and WBC before lens removal at Visit 6 | Eyes | Eyes |
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| Secondary | Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a Scale | VAS, and WBC before lens removal at Visit 6 | Eyes | Eyes |
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| 0 |
| 184 |
| 0 |
| 184 |
| 0 |
| 184 |
| EG001 | Test 2 (Acuvue Oasys 1-Day) | Subjects wore the Test 2 [Acuvue Oasys 1-Day] lens during period 2 of the study | 0 | 48 | 0 | 48 | 0 | 48 |
Not provided
Lower Lid |
| Generalized Linear Mixed Model |
The Kenward and Roger Method was used for the denominator degrees of freedom. |
| Mean Ratio |
| 1.800 |
| 1-Sided |
| 95 |
| 1.093 |
Mean Ratio was calculated as Symptomatic divided by Asymptomatic |
| Other |
Statistical Difference |