Visual AcuityNCT03871543

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

A study testing AquaComfort Plus and Acuvue Oasys 1-Day in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: AquaComfort Plus and Acuvue Oasys 1-Day
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Apr 2019to 3 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 11Show fewer

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

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate contact lens wear.
No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
They have had cataract surgery.

Show all 14Show fewer

They have had corneal refractive surgery.
They are pregnant or breast-feeding.
They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
They have taken part in any other clinical trial or research within two weeks prior to starting this study.
History of allergy to sodium fluorescein or lissamine green.
They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The University of Manchester - Eurolens Research
Manchester

Other trials in United Kingdom

About this study

Conditions: Visual Acuity
Being tested: AquaComfort Plus, Acuvue Oasys 1-Day

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AquaComfort PlusDevice
Test Lens 1
Acuvue Oasys 1-DayDevice
Test Lens 2

Study groups in NCT03871543
Study group	Role	What they receive
Part 1	Other	All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1 Receives: Device: AquaComfort Plus
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. Receives: Device: Acuvue Oasys 1-Day

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 Hours Follow-up at Visit 4
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.
Measured: 2-Week Follow-up (after 6 hours lens wear) at Visit 2

Secondary outcomes (12)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: VAS, and WBC before lens removal at Visit 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20193 Feb 2022

First posted12 Mar 2019
Study start1 Apr 2019
Primary completion3 Feb 2022
Study completion3 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Visual AcuityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03871543
Sponsor's protocol ID: CR-6290
Status last verified: May 2023
First submitted: 4 Mar 2019
Last updated: 16 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration

All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
ClinicalTrials.gov ID: NCT03871543
Acronym / sponsor ID: CR-6290
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2019 (actual)
Primary completion: 3 Feb 2022 (actual)
Study completion: 3 Feb 2022 (actual)
First posted: 12 Mar 2019 (actual)
Results: Posted 16 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1	Other	Device: AquaComfort PlusAll eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1
Part 2	Other	Device: Acuvue Oasys 1-DayAll 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AquaComfort PlusTest Lens 1	Device	Part 1
Acuvue Oasys 1-DayTest Lens 2	Device	Part 2

Primary outcome

Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)
Time frame: 14 Hours Follow-up at Visit 4
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.
Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)
Time frame: 14 Hours Follow-up at Visit 4
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.
Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)
Time frame: 14 Hours Follow-up at Visit-4
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.
Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
Time frame: 14 Hours Follow-up at Visit 4
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.
Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus)
Time frame: 2-Week Follow-up (after 6 hours lens wear) at Visit 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.

12 secondary outcomes

Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: VAS, and WBC before lens removal at Visit 6

Results and safety

Results posted to the registry on 16 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test 1 (Dailies Aqua Comfort Plus) \ Test 2 (Acuvue Oasys 1-Day)	184	48

Primary outcome: Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)

Time frame: 14 Hours Follow-up at Visit 4. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Asymptomatic n = 28	Symptomatic n = 18
Upper Lid	1.02 (0.822)	1.25 (0.943)
Lower Lid	1.45 (0.896)	1.78 (0.988)

Asymptomatic vs Symptomatic: Mean difference: 0.159, Mixed Models Analysis
Asymptomatic vs Symptomatic: Mean Difference: 0.236, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)

Time frame: 14 Hours Follow-up at Visit 4. Mean (Standard Deviation). Unit: Seconds

Measure	Asymptomatic n = 28	Symptomatic n = 18
Value	4.43 (3.386)	4.32 (3.613)

Asymptomatic vs Symptomatic: Mean Ratio: 0.918, Generalized Linear Mixed Model

Primary outcome: Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)

Time frame: 14 Hours Follow-up at Visit-4. Mean (Standard Deviation). Unit: mm

Measure	Asymptomatic n = 28	Symptomatic n = 18
Value	0.20 (0.058)	0.19 (0.069)

Asymptomatic vs Symptomatic: Mean Difference: -0.010, Mixed Models Analysis

Primary outcome: Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)

Time frame: 14 Hours Follow-up at Visit 4. Mean (Standard Deviation). Unit: mOsms/L

Measure	Asymptomatic n = 28	Symptomatic n = 18
Value	299.00 (12.098)	301.89 (12.107)

Asymptomatic vs Symptomatic: Mean Difference: 1.185, Mixed Models Analysis

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1 (Dailies Aqua Comfort Plus)	0 of 184 (0%)	0 of 184 (0%)	0 of 184
Test 2 (Acuvue Oasys 1-Day)	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

Related trials for Visual Acuity

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Johnson & Johnson Vision Care, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AquaComfort Plus and Acuvue Oasys 1-Day in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) (time frame: 14 Hours Follow-up at Visit 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.