CClinicalTrials.gg
Sign In
CompletedNCT03871543Updated May 16, 2023Results posted

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

An interventional study of AquaComfort Plus and Acuvue Oasys 1-Day in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Potential subjects must satisfy all of the criteria listed to be enrolled in the study.

    1. They are 18-45 years of age (inclusive).
    2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
    3. They are willing and able to follow the protocol.
    4. They agree not to participate in other clinical research while enrolled on this study.
    5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
    6. They agree to wear their lenses for at least 12-14 hours per day.
    7. They own a wearable pair of spectacles (by self-report).
    8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
    9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
    10. They have best corrected distance visual acuity of at least 0.20 binocularly

Exclusion criteria

Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. They have an ocular disorder which would normally contraindicate contact lens wear.
    2. They have a systemic disorder which would normally contraindicate contact lens wear.
    3. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
    4. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
    5. They have had cataract surgery.
    6. They have had corneal refractive surgery.
    7. They are pregnant or breast-feeding.
    8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
    9. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
    10. They have taken part in any other clinical trial or research within two weeks prior to starting this study.
    11. History of allergy to sodium fluorescein or lissamine green.
    12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
    13. They any slit lamp findings of Efron Grade 3 or greater (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of \< Grade 3 which in the investigator's opinion would contraindicate contact lens wear.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
196 participants (actual)

Study arms

  • Other
    Part 1

    All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1

    Device: AquaComfort Plus

  • Other
    Part 2

    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.

    Device: Acuvue Oasys 1-Day

Interventions

  • DeviceAquaComfort Plus

    Test Lens 1

  • DeviceAcuvue Oasys 1-Day

    Test Lens 2

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 Hours Follow-up at Visit 4

  2. 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.

    Time frame: 14 Hours Follow-up at Visit 4

  3. 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.

    Time frame: 14 Hours Follow-up at Visit-4

  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.

    Time frame: 14 Hours Follow-up at Visit 4

  5. 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.

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

Secondary outcomes

  1. 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).

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

  2. 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).

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

  3. 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).

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

  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).

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  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).

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

  9. 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).

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

  10. 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).

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

  11. 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).

    Time frame: VAS, and WBC before lens removal at Visit 6

  12. 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).

    Time frame: VAS, and WBC before lens removal at Visit 6

07

Results

Posted May 16, 2023
Limitations and caveats
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.

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.

Period 1
Participant flow — Period 1
MilestoneTest 1 (Dailies Aqua Comfort Plus) \ Test 2 (Acuvue Oasys 1-Day)
Started184
Completed48
Not completed136
Withdrew: Unsatisfactory lens fitting due test article10
Withdrew: Investigator error1
Withdrew: Protocol violation2
Withdrew: Covid-19 related1
Withdrew: Subject no longer meets eligibility criteria112
Withdrew: Withdrawal by subject10
Period 2
Participant flow — Period 2
MilestoneTest 1 (Dailies Aqua Comfort Plus) \ Test 2 (Acuvue Oasys 1-Day)
Started48
Completed46
Not completed2
Withdrew: Adverse event1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryLid 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.

Time frame:
14 Hours Follow-up at Visit 4
Reported as:
Mean · Units on a Scale
Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleAsymptomaticSymptomatic
Upper Lid1.02 ± 0.8221.25 ± 0.943
Lower Lid1.45 ± 0.8961.78 ± 0.988
Statistical analysis
  • Asymptomatic vs Symptomatic · Mixed Models Analysis · Mean difference: 0.159Mean difference was calculated as Symptomatic minus Asymptomatic
  • Asymptomatic vs Symptomatic · Mixed Models Analysis · Mean difference: 0.236Mean difference was calculated as Symptomatic minus Asymptomatic
PrimaryNon-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.

Time frame:
14 Hours Follow-up at Visit 4
Reported as:
Mean · Seconds
Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)
SecondsAsymptomaticSymptomatic
Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)4.43 ± 3.3864.32 ± 3.613
Statistical analysis
  • Asymptomatic vs Symptomatic · Generalized Linear Mixed Model · Mean ratio: 0.918Mean ratio was calculated as Symptomatic divided by Asymptomatic
PrimaryTear 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.

Time frame:
14 Hours Follow-up at Visit-4
Reported as:
Mean · mm
Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)
mmAsymptomaticSymptomatic
Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)0.20 ± 0.0580.19 ± 0.069
Statistical analysis
  • Asymptomatic vs Symptomatic · Mixed Models Analysis · Mean difference: -0.010Mean difference was calculated as Symptomatic minus Asymptomatic
PrimaryTear 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.

Time frame:
14 Hours Follow-up at Visit 4
Reported as:
Mean · mOsms/L
Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
mOsms/LAsymptomaticSymptomatic
Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)299.00 ± 12.098301.89 ± 12.107
Statistical analysis
  • Asymptomatic vs Symptomatic · Mixed Models Analysis · Mean difference: 1.185Mean difference was calculated as Symptomatic minus Asymptomatic
PrimaryNumber 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.

Time frame:
2-Week Follow-up (after 6 hours lens wear) at Visit 2
Reported as:
Mean · number of white blood cells per frame
Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus)
number of white blood cells per frameAsymptomaticSymptomatic
Upper Lid7.94 ± 8.45014.91 ± 12.562
Lower5.89 ± 6.18412.19 ± 12.210
Statistical analysis
  • Asymptomatic vs Symptomatic · Generalized Linear Mixed Model · Mean ratio: 1.984Mean Ratio was calculated as Symptomatic divided by Asymptomatic
  • Asymptomatic vs Symptomatic · Generalized Linear Mixed Model · Mean ratio: 1.800Mean Ratio was calculated as Symptomatic divided by Asymptomatic
SecondaryRelationship 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).

Time frame:
VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)76.24 ± 23.999
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.3446 · Correlation coefficient: -0.1416 · 95% CI -0.4148 to 0.1551Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and TMH 14 Hours Follow-up at Visit 4
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)76.24 ± 23.999
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.5556 · Correlation coefficient: 0.0887 · 95% CI -0.2070 to 0.3694Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)76.24 ± 23.999
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.1676 · Correlation coefficient: -0.2052 · 95% CI -0.4676 to 0.0905Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and NIBUT 14 Hours Follow-up at Visit 4
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)76.24 ± 23.999
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.5483 · Correlation coefficient: 0.0903 · 95% CI -0.2054 to 0.3709Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus)67.05 ± 30.322
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.0719 · Correlation coefficient: -0.2679 · 95% CI -0.5205 to 0.0278Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus)
Units on a ScaleTest 1 (Dailies Aqua Comfort Plus)
Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus)67.05 ± 30.322
Statistical analysis
  • Test 1 (Dailies Aqua Comfort Plus) · Pearson correlation · p = 0.0190 · Correlation coefficient: -0.3434 · 95% CI -0.5786 to 0.0554Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day)85.28 ± 18.439
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.0420 · Correlation coefficient: -0.2975 · 95% CI -0.5410 to -0.0078Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and TMH 14 Hours Follow-up at Visit 8
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day)85.28 ± 18.439
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.3973 · Correlation coefficient: 0.1270 · 95% CI -0.1696 to 0.4024Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and LMS 14 Hours Follow-up at Visit 8
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day)85.28 ± 18.439
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.8894 · Correlation coefficient: -0.0210 · 95% CI -0.3094 to 0.2710Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and LMS 14 Hours Follow-up at Visit 8
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day)85.28 ± 18.439
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.6129 · Correlation coefficient: 0.0762 · 95% CI -0.2190 to 0.3585Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and WBC before lens removal at Visit 6
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day)85.53 ± 20.803
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.3493 · Correlation coefficient: -0.1402 · 95% CI -0.4137 to 0.1565Pearson correlation statistics using Fisher's z transformation
SecondaryRelationship 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).

Time frame:
VAS, and WBC before lens removal at Visit 6
Reported as:
Mean · Units on a Scale
Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day)
Units on a ScaleTest 2 (Acuvue Oasys 1-Day)
Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day)85.53 ± 20.803
Statistical analysis
  • Test 2 (Acuvue Oasys 1-Day) · Pearson correlation · p = 0.4270 · Correlation coefficient: -0.1192 · 95% CI -0.3958 to 0.1772Pearson correlation statistics using Fisher's z transformation

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test 1 (Dailies Aqua Comfort Plus)0/184 (0%)0/184 (0%)0/184 (0%)
Test 2 (Acuvue Oasys 1-Day)0/48 (0%)0/48 (0%)0/48 (0%)

Baseline characteristics

All subjects dispensed at least one study lens.

Age, Continuous
Age, Continuous(Years)AsymptomaticSymptomaticOtherUnknownTotal
Mean28 ± 6.6727.8 ± 7.0925.1 ± 6.3228.1 ± 8.8327.1 ± 6.92
Sex: Female, Male
Sex: Female, Male(Participants)AsymptomaticSymptomaticOtherUnknownTotal
Female62164511134
Male26413750
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AsymptomaticSymptomaticOtherUnknownTotal
American Indian or Alaska Native00000
Asian9523845
Native Hawaiian or Other Pacific Islander00000
Black or African American814013
White69132710119
More than one race00000
Unknown or Not Reported21407
08

Study locations

1 site
  • The University of Manchester - Eurolens Research
    Manchester, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 23, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03871543
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Mar 12, 2019
Start date
Apr 1, 2019
Primary completion
Feb 3, 2022
Completion
Feb 3, 2022
Results posted
May 16, 2023
Last update
May 16, 2023

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Johnson & Johnson Vision Care, Inc.

Start the discussion