Evaluation of Effect of Scatter on Visual Performance

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.

Study Overview

• Status: Recruiting
• Conditions: Visual Acuity
• Intervention / Treatment: Device: ACUVUE® OASYS 1-Day Sphere; Device: ACUVUE® OASYS Multifocal

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 1-800-843-2020; Email: NJoshi30@ITS.JNJ.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • VRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Lens for non-Presbyopes; Device: ACUVUE® OASYS Multifocal; Lens for Prebyopes
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; Lens for non-Presbyopes; Device: ACUVUE® OASYS Multifocal; Lens for Prebyopes
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; Lens for non-Presbyopes; Device: ACUVUE® OASYS Multifocal; Lens for Prebyopes
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; Lens for non-Presbyopes; Device: ACUVUE® OASYS Multifocal; Lens for Prebyopes
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; Lens for non-Presbyopes; Device: ACUVUE® OASYS Multifocal; Lens for Prebyopes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 Post lens fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): May 22, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CR-6626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No