Visual AcuityNCT05601544
The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
A study testing ACUVUE OASYS 1-Day, ACUVUE OASYS MAX 1-Day and ACUVUE OASYS Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- ACUVUE OASYS 1-Day, ACUVUE OASYS MAX 1-Day and ACUVUE OASYS Multifocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2022to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ACUVUE OASYS 1-Day, ACUVUE OASYS MAX 1-Day, ACUVUE OASYS Multifocal, ACUVUE OASYS MAX 1-Day Multifocal, ACUVUE OASYS 1-Day for Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE OASYS 1-DayDevice
Sphere CONTROL
ACUVUE OASYS MAX 1-DayDevice
Sphere TEST
ACUVUE OASYS MultifocalDevice
Multifocal CONTROL
ACUVUE OASYS MAX 1-Day MultifocalDevice
Multifocal TEST
ACUVUE OASYS 1-Day for AstigmatismDevice
Toric CONTROL
senofilcon A based contact lens (toric) with new UV/HEV filterDevice
Toric TEST
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: ACUVUE OASYS 1-Day for Astigmatism; Device: senofilcon A based contact lens (toric) with new UV/HEV filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 15 minutes post lens fitting
Secondary outcomes (2)
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.
Measured: 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.
Measured: Approximately 15 minutes post lens fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start9 Dec 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601544
- Sponsor's protocol ID
- CR-6480
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2022
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
- ClinicalTrials.gov ID
- NCT05601544
- Acronym / sponsor ID
- CR-6480
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sphere TEST/CONTROL | Experimental | Device: ACUVUE OASYS 1-Day, Device: ACUVUE OASYS MAX 1-DayEligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere TEST/CONTROL sequence. |
| Sphere CONTROL/TEST | Experimental | Device: ACUVUE OASYS 1-Day, Device: ACUVUE OASYS MAX 1-DayEligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere CONTROL/TEST sequence. |
| Multifocal TEST/CONTROL | Experimental | Device: ACUVUE OASYS Multifocal, Device: ACUVUE OASYS MAX 1-Day MultifocalEligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal TEST/CONTROL sequence. |
| Multifocal CONTROL/TEST | Experimental | Device: ACUVUE OASYS Multifocal, Device: ACUVUE OASYS MAX 1-Day MultifocalEligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal CONTROL/TEST sequence. |
| Toric TEST/CONTROL | Experimental | Device: ACUVUE OASYS 1-Day for Astigmatism, Device: senofilcon A based contact lens (toric) with new UV/HEV filterEligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric TEST/CONTROL sequence. |
| Toric CONTROL/TEST | Experimental | Device: ACUVUE OASYS 1-Day for Astigmatism, Device: senofilcon A based contact lens (toric) with new UV/HEV filterEligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric CONTROL/TEST sequence. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- 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.
Key exclusion criteria (14 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACUVUE OASYS 1-DaySphere CONTROL | Device | Sphere CONTROL/TEST, Sphere TEST/CONTROL |
| ACUVUE OASYS MAX 1-DaySphere TEST | Device | Sphere CONTROL/TEST, Sphere TEST/CONTROL |
| ACUVUE OASYS MultifocalMultifocal CONTROL | Device | Multifocal CONTROL/TEST, Multifocal TEST/CONTROL |
| ACUVUE OASYS MAX 1-Day MultifocalMultifocal TEST | Device | Multifocal CONTROL/TEST, Multifocal TEST/CONTROL |
| ACUVUE OASYS 1-Day for AstigmatismToric CONTROL | Device | Toric CONTROL/TEST, Toric TEST/CONTROL |
| senofilcon A based contact lens (toric) with new UV/HEV filterToric TEST | Device | Toric CONTROL/TEST, Toric TEST/CONTROL |
Primary outcome
Visual Range at Phase 1
Time frame: Approximately 15 minutes post lens fitting
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.
Visual Range at Phase 2
Time frame: Approximately 15 minutes post lens fitting
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.
Motion Detection at Phase 1
Time frame: Approximately 15 minutes post lens fitting
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.
Brightness Perception at Phase 1
Time frame: Approximately 15 minutes post lens fitting
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.
2 secondary outcomes
Motion Detection at Phase 2
Time frame: Approximately 15 minutes post lens fitting
Brightness Perception at Phase 2
Time frame: Approximately 15 minutes post lens fitting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUVUE OASYS 1-Day, ACUVUE OASYS MAX 1-Day 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?
The sponsor lists 10 inclusion and 14 exclusion criteria. 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 27 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Range at Phase 1 (time frame: Approximately 15 minutes post lens fitting). The study lists 4 primary outcomes in all. 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 27 Apr 2025.