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

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: ACUVUE OASYS 1-Day; Device: ACUVUE OASYS MAX 1-Day; Device: ACUVUE OASYS Multifocal; Device: ACUVUE OASYS MAX 1-Day Multifocal; Device: ACUVUE OASYS 1-Day for Astigmatism; Device: senofilcon A based contact lens (toric) with new UV/HEV filter

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • The University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

The subject must:

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 70 (inclusive) years of age at the time of screening.
4. 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.
5. 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
6. 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
7. 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
8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

The subject must not:

1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any ocular infection of any type.
3. 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.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing lenses in an extended wear modality.
6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
7. 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.
8. (Phase 2 only): Have participated in Phase 1 of the study.
9. 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).
10. Have a history of strabismus or amblyopia.
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) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sphere TEST/CONTROL; 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; Sphere CONTROL; Device: ACUVUE OASYS MAX 1-Day; Sphere TEST
Experimental: Sphere CONTROL/TEST; 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; Sphere CONTROL; Device: ACUVUE OASYS MAX 1-Day; Sphere TEST
Experimental: Multifocal TEST/CONTROL; 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; Multifocal CONTROL; Device: ACUVUE OASYS MAX 1-Day Multifocal; Multifocal TEST
Experimental: Multifocal CONTROL/TEST; 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; Multifocal CONTROL; Device: ACUVUE OASYS MAX 1-Day Multifocal; Multifocal TEST
Experimental: Toric TEST/CONTROL; 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; Toric CONTROL; Device: senofilcon A based contact lens (toric) with new UV/HEV filter; Toric TEST
Experimental: Toric CONTROL/TEST; 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; Toric CONTROL; Device: senofilcon A based contact lens (toric) with new UV/HEV filter; Toric TEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion Detection at Phase 2	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 2	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

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): December 9, 2022
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CR-6480

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.: Yes