The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

NCT05601544 | Completed Results FDA Device

• 1 other identifier: CR-6480
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2 crossover study to objectively measure potential benefits of a new UV/HEV filter using psychophysical testing techniques.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (4)

• Visual Range at Phase 1

  Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.

  Approximately 15 minutes post lens fitting

• Visual Range at Phase 2

  Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.

  Approximately 15 minutes post lens fitting

• Motion Detection at Phase 1

  Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred.

  Approximately 15 minutes post lens fitting

• Brightness Perception at Phase 1

  Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target.

  Approximately 15 minutes post lens fitting

Secondary Outcomes (2)

• Motion Detection at Phase 2

  Approximately 15 minutes post lens fitting

• Brightness Perception at Phase 2

  Approximately 15 minutes post lens fitting

Study Arms (6)

Sphere TEST/CONTROL

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere TEST/CONTROL sequence.

Device: ACUVUE OASYS 1-Day; Device: ACUVUE OASYS MAX 1-Day

Sphere CONTROL/TEST

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere CONTROL/TEST sequence.

Device: ACUVUE OASYS 1-Day; Device: ACUVUE OASYS MAX 1-Day

Multifocal TEST/CONTROL

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal TEST/CONTROL sequence.

Device: ACUVUE OASYS Multifocal; Device: ACUVUE OASYS MAX 1-Day Multifocal

Multifocal CONTROL/TEST

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal CONTROL/TEST sequence.

Device: ACUVUE OASYS Multifocal; Device: ACUVUE OASYS MAX 1-Day Multifocal

Toric TEST/CONTROL

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric TEST/CONTROL sequence.

Device: ACUVUE OASYS 1-Day for Astigmatism; Device: senofilcon A based contact lens (toric) with new UV/HEV filter

Toric CONTROL/TEST

EXPERIMENTAL

Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric CONTROL/TEST sequence.

Device: ACUVUE OASYS 1-Day for Astigmatism; Device: senofilcon A based contact lens (toric) with new UV/HEV filter

Interventions

ACUVUE OASYS 1-Day DEVICE

Sphere CONTROL

Sphere CONTROL/TEST; Sphere TEST/CONTROL

ACUVUE OASYS MAX 1-Day DEVICE

Sphere TEST

Sphere CONTROL/TEST; Sphere TEST/CONTROL

ACUVUE OASYS Multifocal DEVICE

Multifocal CONTROL

Multifocal CONTROL/TEST; Multifocal TEST/CONTROL

ACUVUE OASYS MAX 1-Day Multifocal DEVICE

Multifocal TEST

Multifocal CONTROL/TEST; Multifocal TEST/CONTROL

ACUVUE OASYS 1-Day for Astigmatism DEVICE

Toric CONTROL

Toric CONTROL/TEST; Toric TEST/CONTROL

senofilcon A based contact lens (toric) with new UV/HEV filter DEVICE

Toric TEST

Toric CONTROL/TEST; Toric TEST/CONTROL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must:
• 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 70 (inclusive) years of age at the time of screening.
• By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
• If applicable, those subjects receiving the spherical lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS
• If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS
• If applicable, those subjects receiving the toric lenses will need a vertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10
• The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• The subject must not:
• Be currently pregnant or lactating.
• Be currently using any ocular medications or have any ocular infection of any type.
• By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded 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 participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• 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.
• (Phase 2 only): Have participated in Phase 1 of the study.
• Have clinically significant (grade 3 or higher on the FDA grading 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 the investigator believes might contraindicate contact lens wear or may 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 a history of strabismus or amblyopia.
• Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
• Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

The University of Georgia

Athens, Georgia, 30602, United States

Location

Results Point of Contact

• Title: Senior Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

jbuch@its.jnj.com

904-608-7238

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: December 9, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: April 27, 2025
• Results First Posted: December 27, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)