Visual AcuityNCT07443215
Evaluation of Effect of Scatter on Visual Performance
A study testing ACUVUE® OASYS 1-Day Sphere and ACUVUE® OASYS Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- ACUVUE® OASYS 1-Day Sphere and ACUVUE® OASYS Multifocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 69 years of age (inclusive) at the time of screening.
- Habitually wear soft contact lenses (either spherical or multifocal) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
- Possess a wearable pair of spectacles that provide correction for distance vision.
- Have the spherical component of their vertex-corrected distance refraction within the range +3.00 to -5.00 DS (inclusive) in both eyes.
- Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 1.00 DC in both eyes.
- Have best corrected monocular distance VA of 20/25 or better in each eye.
- Have Near Addition with Add refinement following BCC<0.75D (Non-presbyopic group only).
- Have Near Addition with Add refinement following BCC≥0.75D (Presbyopic group only).
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- Be currently wearing lenses in an extended wear modality.
- Have a history of strabismus or amblyopia.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter.
Read the detailed description
Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.
- Conditions
- Visual Acuity
- Being tested
- ACUVUE® OASYS 1-Day Sphere, ACUVUE® OASYS Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE® OASYS 1-Day SphereDevice
Lens for non-Presbyopes
ACUVUE® OASYS MultifocalDevice
Lens for Prebyopes
| Study group | Role | What they receive |
|---|---|---|
| No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm | Experimental | Eligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence Receives: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal |
| Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter | Experimental | Eligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence Receives: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal |
| Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm | Experimental | Eligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence Receives: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal |
| Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm | Experimental | Eligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence Receives: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal |
| Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm | Experimental | Eligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence Receives: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA)
Distance (4 meters) Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) without glare will be assessed after lens fitting.
Measured: Day 1 Post lens fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start13 Feb 2026
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443215
- Sponsor's protocol ID
- CR-6626
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Scatter on Visual Performance
- ClinicalTrials.gov ID
- NCT07443215
- Acronym / sponsor ID
- CR-6626
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter.
Detailed description
Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm | Experimental | Device: ACUVUE® OASYS 1-Day Sphere, Device: ACUVUE® OASYS MultifocalEligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence |
| Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter | Experimental | Device: ACUVUE® OASYS 1-Day Sphere, Device: ACUVUE® OASYS MultifocalEligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence |
| Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm | Experimental | Device: ACUVUE® OASYS 1-Day Sphere, Device: ACUVUE® OASYS MultifocalEligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence |
| Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm | Experimental | Device: ACUVUE® OASYS 1-Day Sphere, Device: ACUVUE® OASYS MultifocalEligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence |
| Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm | Experimental | Device: ACUVUE® OASYS 1-Day Sphere, Device: ACUVUE® OASYS MultifocalEligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ACUVUE® OASYS 1-Day SphereLens for non-Presbyopes | Device | Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm, Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter, Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm, Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm, No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm |
| ACUVUE® OASYS MultifocalLens for Prebyopes | Device | Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm, Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter, Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm, Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm, No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm |
Primary outcome
Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA)
Time frame: Day 1 Post lens fitting
Distance (4 meters) Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) without glare will be assessed after lens fitting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- 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
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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 ACUVUE® OASYS 1-Day Sphere and ACUVUE® OASYS Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Sep 2026. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) (time frame: Day 1 Post lens fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.