AzTrials
AzTrials

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.

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 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:

  1. Read, understand, and sign the Statement of Informed Consent 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 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.
  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 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).
  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.)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VRC

    Jacksonville, Florida, 32256

Other trials in United States

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 groups in NCT07443215
Study groupRoleWhat they receive
No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mmExperimentalEligible 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 filterExperimentalEligible 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 1/4mmExperimentalEligible 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 1/2mmExperimentalEligible 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 1mmExperimentalEligible 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.

  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.

    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.

  1. First posted2 Mar 2026
  2. Study start13 Feb 2026
  3. Primary completion22 May 2026
  4. Study completion22 May 2026

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in