Visual AcuityNCT05361304

Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity.

A study testing senofilcon A contact lenses made with a novel manufacturing technology and senofilcon A contact lenses made with the current manufacturing technology in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites 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 study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity. Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: senofilcon A contact lenses made with a novel manufacturing technology and senofilcon A contact lenses made with the current manufacturing technology
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 6 sitesUnited States
Study dates: 16 May 2022to 5 Jul 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 39 years
All sexes
Healthy volunteers accepted
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.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical soft silicone hydrogel 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.
Possess a wearable pair of spectacles that provide correction for distance vision.

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The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (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:
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.
Be currently wearing monovision or multifocal contact lenses.
Be currently wearing lenses in an extended wear modality.

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Have participated in a contact lens or lens care product clinical trial within 7 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 will 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). (Specify method of determination if needed).
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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

VRC
Jacksonville, Florida, 32256
Flora Chen Poveda OD, PA - Orange Park
Orange Park, Florida, 32073
Botetourt Eyecare, LLC
Salem, Virginia, 24153
William J. Bogus, O.D.
Salt Lake City, Utah, 84106
Tallahassee Eye Center
Tallahassee, Florida, 32308
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

About this study

Official title: Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.

Conditions: Visual Acuity
Being tested: senofilcon A contact lenses made with a novel manufacturing technology, senofilcon A contact lenses made with the current manufacturing technology

What participants receive

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

senofilcon A contact lenses made with a novel manufacturing technologyDevice
TEST Lens
senofilcon A contact lenses made with the current manufacturing technologyDevice
CONTROL Lens

Study groups in NCT05361304
Study group	Role	What they receive
TEST Lens	Experimental	Eligible subjects who are habitual soft contact lens wearers will be randomized into the TEST Lens for the duration of the study. Receives: Device: senofilcon A contact lenses made with a novel manufacturing technology
CONTROL Lens	Experimental	Eligible subjects who are habitual soft contact lens wearers will be randomized into the CONTROL Lens for the duration of the study. Receives: Device: senofilcon A contact lenses made with the current manufacturing technology

What is being measured

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

Monocular logMAR Visual Acuity
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 2-Week Follow-up
Average Daily Wearing Time
Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.
Measured: 2-Week Follow-up

Secondary outcomes (2)

CLUE Comfort Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported.
Measured: 2-Week Follow-up
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.
Measured: 2-Week Follow-up

Timeline

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

16 May 20225 Jul 2022

First posted4 May 2022
Study start16 May 2022
Primary completion5 Jul 2022
Study completion5 Jul 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.
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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05361304
Sponsor's protocol ID: CR-6474
Status last verified: Jun 2023
First submitted: 29 Apr 2022
Last updated: 13 Jul 2023
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

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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology
ClinicalTrials.gov ID: NCT05361304
Acronym / sponsor ID: CR-6474
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 16 May 2022 (actual)
Primary completion: 5 Jul 2022 (actual)
Study completion: 5 Jul 2022 (actual)
First posted: 4 May 2022 (actual)
Results: Posted 13 Jul 2023

Clinical summary

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

This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TEST Lens	Experimental	Device: senofilcon A contact lenses made with a novel manufacturing technologyEligible subjects who are habitual soft contact lens wearers will be randomized into the TEST Lens for the duration of the study.
CONTROL Lens	Experimental	Device: senofilcon A contact lenses made with the current manufacturing technologyEligible subjects who are habitual soft contact lens wearers will be randomized into the CONTROL Lens for the duration of the study.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 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 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical soft silicone hydrogel 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 (11 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.
Be currently wearing monovision or multifocal contact lenses.

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
senofilcon A contact lenses made with a novel manufacturing technologyTEST Lens	Device	TEST Lens
senofilcon A contact lenses made with the current manufacturing technologyCONTROL Lens	Device	CONTROL Lens

Primary outcome

Monocular logMAR Visual Acuity
Time frame: 2-Week Follow-up
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Average Daily Wearing Time
Time frame: 2-Week Follow-up
Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.

2 secondary outcomes

CLUE Comfort Score
Time frame: 2-Week Follow-up
CLUE Vision Score
Time frame: 2-Week Follow-up

Results and safety

Results posted to the registry on 13 Jul 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
Senofilcon A Contact Lenses Made With the Current Manufacturing Technology	62	59
Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology	61	59

Primary outcome: Monocular logMAR Visual Acuity

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n = 59	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n = 59
High Luminance Low Contrast	0.051 (0.1082)	0.032 (0.0947)
Low Luminance High Contrast	0.044 (0.1042)	0.036 (0.0830)

Senofilcon A Contact Lenses Made With the Current Manufacturing Technology vs Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology: Least square Mean (LSM) Difference: -0.020 (95% CI -0.040 to 0.000), Linear Mixed Model
Senofilcon A Contact Lenses Made With the Current Manufacturing Technology vs Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology: Least square Mean (LSM) Difference: -0.010 (95% CI -0.030 to 0.020), Linear Mixed Model

Population analysed: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

Primary outcome: Average Daily Wearing Time

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: hours

Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n = 59	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n = 59
Value	14.2 (2.12)	14.5 (1.97)

Senofilcon A Contact Lenses Made With the Current Manufacturing Technology vs Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology: Least square Mean (LSM) Difference: 0.270 (95% CI -0.460 to 1.010), Linear Mixed Model

Population analysed: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study; The study duration for each subject was approximately 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A Contact Lenses Made With the Current Manufacturing Technology	0 of 62 (0%)	0 of 62 (0%)	0 of 62
Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 11 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 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 13 Jul 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?

Monocular logMAR Visual Acuity (time frame: 2-Week Follow-up). The study lists 2 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 NCT05361304.

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 13 Jul 2023.