Visual PerformanceNCT05021081

Visual Performance of Senofilcon A With and Without a New UV/HEV-filter

A study testing TRP-200 and ACUVUE Oasys 1-Day in people with Visual Performance, 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

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Visual Performance
What is being tested?: TRP-200 and ACUVUE Oasys 1-Day
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 23 Aug 2021to 20 Oct 2021
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:
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.
For Phase I be between 18-39 (inclusive) years of age at the time of screening.
For Phase II be between 18 and 70 (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.
Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.
For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.
For Phase II, 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.
For Phase II, 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.
For Phase II, 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:
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 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.
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 monovision or multifocal contact lenses.

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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 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 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 study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.

Conditions: Visual Performance
Being tested: TRP-200, ACUVUE Oasys 1-Day

What participants receive

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

TRP-200Device
Also called TEST
JJVC Investigational Contact Lens
ACUVUE Oasys 1-DayDevice
Also called CONTROL
JJVC Marketed Contact Lens

Study groups in NCT05021081
Study group	Role	What they receive
TEST/CONTROL	Experimental	For Phase 2, eligible subjects that are enrolled will be randomized to the Test/Control contralateral sequence. Receives: Device: TRP-200; Device: ACUVUE Oasys 1-Day
CONTROL/TEST	Experimental	For Phase 2, eligible subjects that are enrolled will be randomized to the Control/Test contralateral sequence. Receives: Device: TRP-200; Device: ACUVUE Oasys 1-Day

What is being measured

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

Photopic Contrast Sensitivity at 6 Cpd
Photopic (~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Measured: Post screening up to 1 hour during Phase 1
Mesopic Contrast Sensitivity at 6 Cpd
Mesopic (~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Measured: Post screening up to 1 hour during Phase 1
Photopic Resolution Acuity Using Landolt C's With a Glare Source
Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.
Measured: At least 5 minutes post lens fitting up to 2 hours during Phase 2

Secondary outcomes (2)

Photopic Contrast Sensitivity With a Glare Source
Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Measured: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Mesopic Contrast Sensitivity With a Glare Source
Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Measured: At least 5 minutes post lens fitting up to 2 hours during Phase 2

Timeline

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

23 Aug 202120 Oct 2021

First posted25 Aug 2021
Study start23 Aug 2021
Primary completion20 Oct 2021
Study completion20 Oct 2021

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 PerformanceStudies 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
Model description: In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05021081
Sponsor's protocol ID: CR-6463
Status last verified: Jan 2023
First submitted: 19 Aug 2021
Last updated: 26 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
ClinicalTrials.gov ID: NCT05021081
Acronym / sponsor ID: CR-6463
Conditions: Visual Performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2021 (actual)
Primary completion: 20 Oct 2021 (actual)
Study completion: 20 Oct 2021 (actual)
First posted: 25 Aug 2021 (actual)
Results: Posted 26 Jan 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.

Arm	Type	Receives
TEST/CONTROL	Experimental	Device: TRP-200, Device: ACUVUE Oasys 1-DayFor Phase 2, eligible subjects that are enrolled will be randomized to the Test/Control contralateral sequence.
CONTROL/TEST	Experimental	Device: TRP-200, Device: ACUVUE Oasys 1-DayFor Phase 2, eligible subjects that are enrolled will be randomized to the Control/Test contralateral sequence.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (15 listed)

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

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
TRP-200Also: TESTJJVC Investigational Contact Lens	Device	CONTROL/TEST, TEST/CONTROL
ACUVUE Oasys 1-DayAlso: CONTROLJJVC Marketed Contact Lens	Device	CONTROL/TEST, TEST/CONTROL

Primary outcome

Photopic Contrast Sensitivity at 6 Cpd
Time frame: Post screening up to 1 hour during Phase 1
Photopic (~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Mesopic Contrast Sensitivity at 6 Cpd
Time frame: Post screening up to 1 hour during Phase 1
Mesopic (~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Photopic Resolution Acuity Using Landolt C's With a Glare Source
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.

2 secondary outcomes

Photopic Contrast Sensitivity With a Glare Source
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Mesopic Contrast Sensitivity With a Glare Source
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OD: Test (Senofilcon A C3) /OS: Control (Senofilcon A C3) (Phase 2)	0	0
OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) (Phase 2)	0	0
Subjects' Own Contact Lens (Phase 1)	20	20

Primary outcome: Photopic Contrast Sensitivity at 6 Cpd

Time frame: Post screening up to 1 hour during Phase 1. Mean (Standard Deviation). Unit: Log Unit

Measure	With Glare n = 15	Without Glare n = 15
Value	1.46 (0.317)	1.91 (0.373)

With Glare vs Without Glare: Least-square Mean Difference: -0.45 (95% CI -0.70 to -0.21), Linear Mixed Model

Population analysed: All subjects that completed Phase 1 without a major protocol deviation excluding subjects recording an increase in photopic contrast sensitivity with the glare source.

Primary outcome: Mesopic Contrast Sensitivity at 6 Cpd

Time frame: Post screening up to 1 hour during Phase 1. Mean (Standard Deviation). Unit: Log Unit

Measure	With Glare n = 14	Without Glare n = 14
Value	0.70 (0.328)	1.29 (0.498)

With Glare vs Without Glare: Least-square Mean Difference: -0.58 (95% CI -0.81 to -0.36), Linear Mixed Model

Population analysed: All subjects completed Phase 1 without a major protocol deviation excluding subjects recording an increase in mesopic contrast sensitivity with the glare source.

Primary outcome: Photopic Resolution Acuity Using Landolt C's With a Glare Source

Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2. Mean (Standard Deviation). Unit: logMAR

Measure	Test (Senofilcon A C3) n = 62	Control (Senofilcon A C3) n = 62
Value	0.01 (0.191)	-0.01 (0.158)

Test (Senofilcon A C3) vs Control (Senofilcon A C3): Least-square Mean Difference: 0.019 (95% CI -0.029 to 0.068), Linear Mixed Model

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study; Phase 1 was approximately 1 hour per subject. Phase 2 was approximately 3 hours per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 - Senofilcon A (1-Day)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 1 - Senofilcon A (2-week Reusable)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase 1 - Senofilcon A C3	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Phase 1 - Lotrafilcon B	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Phase 1 - Comifilcon A	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Phase 1 - Somofilcon A	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase 1 -Delefilcon A	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Phase 1 -Stenfilcon A	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Phase 2 - Control (Senofilcon A C3)	0 of 62 (0%)	0 of 62 (0%)	0 of 62
Phase 2 - Test (Senofilcon A C3)	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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 TRP-200 and ACUVUE Oasys 1-Day in people with Visual Performance, 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 12 inclusion and 15 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 26 Jan 2023. 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 26 Jan 2023). 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?

Photopic Contrast Sensitivity at 6 Cpd (time frame: Post screening up to 1 hour during Phase 1). The study lists 3 primary outcomes in all. 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 NCT05021081.

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 26 Jan 2023.