ClinicalTrials.gg
CompletedNCT07443215Updated Sep 25, 2026

Evaluation of Effect of Scatter on Visual Performance

An interventional study of ACUVUE® OASYS 1-Day Sphere and ACUVUE® OASYS Multifocal in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the Statement of and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 69 years of age (inclusive) at the time of screening.
  4. 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.
  5. Possess a wearable pair of spectacles that provide correction for distance vision.
  6. Have the spherical component of their vertex-corrected distance refraction within the range +3.00 to -5.00 DS (inclusive) in both eyes.
  7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 1.00 DC in both eyes.
  8. Have best corrected monocular distance VA of 20/25 or better in each eye.
  9. Have Near Addition with Add refinement following BCC\<0.75D (Non-presbyopic group only).
  10. 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:

  1. Be currently pregnant or lactating.
  2. Be diabetic.
  3. Be currently using any ocular medications or have an ocular infection of any type.
  4. 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 disease (e.g., [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.
  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
  6. Be currently wearing lenses in an extended wear modality.
  7. Have a history of strabismus or amblyopia.
  8. 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.
  9. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  10. Have (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).
  11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm

    Eligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence

    Device: ACUVUE® OASYS 1-Day Sphere · Device: ACUVUE® OASYS Multifocal

  • Experimental
    Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter

    Eligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence

    Device: ACUVUE® OASYS 1-Day Sphere · Device: ACUVUE® OASYS Multifocal

  • Experimental
    Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm

    Eligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence

    Device: ACUVUE® OASYS 1-Day Sphere · Device: ACUVUE® OASYS Multifocal

  • Experimental
    Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm

    Eligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence

    Device: ACUVUE® OASYS 1-Day Sphere · Device: ACUVUE® OASYS Multifocal

  • Experimental
    Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm

    Eligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence

    Device: ACUVUE® OASYS 1-Day Sphere · Device: ACUVUE® OASYS Multifocal

Interventions

  • DeviceACUVUE® OASYS 1-Day Sphere

    Lens for non-Presbyopes

  • DeviceACUVUE® OASYS Multifocal

    Lens for Prebyopes

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 Post lens fitting

07

Study locations

1 site
  • VRC
    Jacksonville, Florida 32256, United States
08

References and documents

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

Data sharing details ↗ · yoda.yale.edu

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2026 to primary completion in May 2026, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2026
First posted
Mar 2, 2026
StartActual
Feb 13, 2026
Primary completionActual
May 22, 2026
CompletionActual
May 22, 2026
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07443215
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Feb 13, 2026
Primary completion
May 22, 2026
Completion
May 22, 2026
Last update
Sep 25, 2026

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 Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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