Evaluation of Effect of Scatter on Visual Performance

NCT07443215 | Recruiting FDA Device

• 1 other identifier: CR-6626
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visual Acuity

Outcome Measures

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.

  Day 1 Post lens fitting

Study Arms (5)

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

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

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

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

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

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

Interventions

ACUVUE® OASYS 1-Day Sphere DEVICE

Lens for non-Presbyopes

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 Multifocal DEVICE

Lens for Prebyopes

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

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

VRC

Jacksonville, Florida, 32256, United States

RECRUITING

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

1-800-843-2020; NJoshi30@ITS.JNJ.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 2, 2026
• Study Start: February 13, 2026
• Primary Completion: May 22, 2026
• Study Completion: May 22, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)