Visual AcuityNCT05582304

Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study

A study testing Test Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Test Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2022to 8 Dec 2022
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 65 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 65 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel soft contact lenses 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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Possess a wearable pair of spectacles that provide correction for distance vision.
The spherical equivalent of the subject's vertex corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
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 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.

Show all 16Show fewer

Be currently wearing monovision or multifocal contact lenses.
Be currently wearing lenses in an extended wear modality.
Have participated in a contact lens or lens care product clinical trial within 30 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.
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 any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Georgia
Athens, Georgia, 30602

Other trials in United States

About this study

This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.

Conditions: Visual Acuity
Being tested: Test Lens, Control Lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test LensDevice
ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter
Control LensDevice
ACUVUE OASYS 1-Day with HydraLuxe Technology

Study groups in NCT05582304
Study group	Role	What they receive
TEST/CONTROL/Photopic CSF	Experimental	Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the TEST/CONTROL lenses. Receives: Device: Test Lens; Device: Control Lens
TEST/CONTROL/Mesopic CSF	Experimental	Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the TEST/CONTROL lenses. Receives: Device: Test Lens; Device: Control Lens
CONTROL/TEST/Photopic CSF	Experimental	Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the CONTROL/TEST lenses. Receives: Device: Test Lens; Device: Control Lens
CONTROL/TEST/Mesopic CSF	Experimental	Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the CONTROL/TEST lenses. Receives: Device: Test Lens; Device: Control Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source
Photopic contrast sensitivity was measured under bright light conditions (~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd).
Measured: Up to 2 hours post-fitting

Secondary outcomes (1)

Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source.
Mesopic contrast sensitivity was measured under dim light conditions (~3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd).
Measured: Up to 2 hours post-fitting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 20228 Dec 2022

First posted17 Oct 2022
Study start31 Oct 2022
Primary completion8 Dec 2022
Study completion8 Dec 2022

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.
Publications (1)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05582304
Sponsor's protocol ID: CR-6501
Status last verified: Jan 2024
First submitted: 13 Oct 2022
Last updated: 31 Jan 2024
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

Publications

Hammond BR, Buch JR, Martin P, Xu J, Renzi-Hammond LM. Effects of HEV-Filtering in a Soft Contact Lens on Contrast Sensitivity With and Without Veiling Glare. Eye Contact Lens. 2026 Jun 22. doi: 10.1097/ICL.0000000000001296. Online ahead of print.
PubMed 42319244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study
ClinicalTrials.gov ID: NCT05582304
Acronym / sponsor ID: CR-6501
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 31 Oct 2022 (actual)
Primary completion: 8 Dec 2022 (actual)
Study completion: 8 Dec 2022 (actual)
First posted: 17 Oct 2022 (actual)
Results: Posted 31 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
TEST/CONTROL/Photopic CSF	Experimental	Device: Test Lens, Device: Control LensEligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the TEST/CONTROL lenses.
TEST/CONTROL/Mesopic CSF	Experimental	Device: Test Lens, Device: Control LensEligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the TEST/CONTROL lenses.
CONTROL/TEST/Photopic CSF	Experimental	Device: Test Lens, Device: Control LensEligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the CONTROL/TEST lenses.
CONTROL/TEST/Mesopic CSF	Experimental	Device: Test Lens, Device: Control LensEligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the CONTROL/TEST lenses.

Who may qualify

Ages: 18 to 65 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 65 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel soft contact lenses 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 (16 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 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
Test LensACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter	Device	CONTROL/TEST/Mesopic CSF, CONTROL/TEST/Photopic CSF, TEST/CONTROL/Mesopic CSF, TEST/CONTROL/Photopic CSF
Control LensACUVUE OASYS 1-Day with HydraLuxe Technology	Device	CONTROL/TEST/Mesopic CSF, CONTROL/TEST/Photopic CSF, TEST/CONTROL/Mesopic CSF, TEST/CONTROL/Photopic CSF

Primary outcome

Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source
Time frame: Up to 2 hours post-fitting
Photopic contrast sensitivity was measured under bright light conditions (~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd).

1 secondary outcome

Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source.
Time frame: Up to 2 hours post-fitting

Results and safety

Results posted to the registry on 31 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Photopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3)	9	9
Photopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3)	11	11
Mesopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3)	11	11
Mesopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3)	9	9

Primary outcome: Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source

Time frame: Up to 2 hours post-fitting. Mean (Standard Deviation). Unit: log(sensitivity)*log(cpd)

Measure	Test (Senofilcon A C3) n = 20	Control (Senofilcon A C3) n = 20
Value	1.92 (0.220)	1.62 (0.158)

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately three hours per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test (Senofilcon A C3)	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Control (Senofilcon A C3)	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42319244Hammond BR, Buch JR, Martin P, Xu J, Renzi-Hammond LM. Effects of HEV-Filtering in a Soft Contact Lens on Contrast Sensitivity With and Without Veiling Glare. Eye Contact Lens. 2026 Jun 22. doi: 10.1097/ICL.0000000000001296. Online ahead of print.
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 Test Lens 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 16 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 31 Jan 2024. 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 31 Jan 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?

Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source (time frame: Up to 2 hours post-fitting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05582304, which also lists 1 linked publication.

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 31 Jan 2024.