Visual AcuityNCT04073186

Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia

A study testing ACUVUE® OASYS with Transitions™ in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 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 is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: ACUVUE® OASYS with Transitions™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 5 sitesUnited States
Study dates: 7 Aug 2019to 20 Mar 2020
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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential subjects must satisfy all 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.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 40 and 70 years of age at the time of screening.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must be an adapted monovision soft contact lens wearer in both eyes (i.e., worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).

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The subject's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.
The subject's refractive cylinder must be ≤1.00 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have best corrected distance visual acuity of 20/20-3 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:
Currently Pregnant or lactating.
Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.
Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, dacryocystorhinostomy, etc.).
Use of any ocular medication, with the exception of rewetting drops.

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Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.
History of herpetic keratitis.
Entropion, ectropion, chalazia, glaucoma, history of recurrent corneal erosions.
A history of amblyopia, strabismus or binocular vision abnormality.
Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Any ocular infection or inflammation.
Any ocular abnormality that may interfere with contact lens wear.
Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Western Reserve Vision Care, Inc.
Beachwood, Ohio, 44122
VRC-East
Jacksonville, Florida, 32256
Manhattan Vision Associates
New York, New York, 10022
Advanced Eyecare
Raytown, Missouri, 64133
Dr. David W. Ferris & Associates
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Conditions: Visual Acuity
Being tested: ACUVUE® OASYS with Transitions™

What participants receive

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

ACUVUE® OASYS with Transitions™Device
JJVC Marketed Contact Lens

Study groups in NCT04073186
Study group	Role	What they receive
ACUVUE® OASYS with Transitions™	Experimental	Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles. Receives: Device: ACUVUE® OASYS with Transitions™

What is being measured

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

Vision Scores
Vision Scores were 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.
Measured: 2-Week Follow-up
Visual Performance (logMAR)
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2).
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

Secondary outcomes (1)

CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle
Vision Scores wwere 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.
Measured: Up to 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.

7 Aug 201920 Mar 2020

First posted29 Aug 2019
Study start7 Aug 2019
Primary completion20 Mar 2020
Study completion20 Mar 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04073186
Sponsor's protocol ID: CR-6349
Status last verified: Aug 2022
First submitted: 28 Aug 2019
Last updated: 10 Aug 2022
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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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia
ClinicalTrials.gov ID: NCT04073186
Acronym / sponsor ID: CR-6349
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 7 Aug 2019 (actual)
Primary completion: 20 Mar 2020 (actual)
Study completion: 20 Mar 2020 (actual)
First posted: 29 Aug 2019 (actual)
Results: Posted 18 May 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ACUVUE® OASYS with Transitions™	Experimental	Device: ACUVUE® OASYS with Transitions™Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (16 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
ACUVUE® OASYS with Transitions™JJVC Marketed Contact Lens	Device	ACUVUE® OASYS with Transitions™

Primary outcome

Vision Scores
Time frame: 2-Week Follow-up
Vision Scores were 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.
Visual Performance (logMAR)
Time frame: 2-Week Follow-up
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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.

1 secondary outcome

CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle
Time frame: Up to 2-Week Follow-up

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test	86	80

Primary outcome: Vision Scores

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Test (First Wearing Cycle) n = 76	Test (Second Wearing Cycle) n = 76
Value	59.38 (19.700)	56.19 (23.387)

Test (First Wearing Cycle): Least-square Mean: 59.3 (95% CI 54.6 to 64.0), Linear Mixed Model

Population analysed: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Primary outcome: Visual Performance (logMAR)

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

Measure	Test (First Wearing Cycle) n = 76	Test (Second Wearing Cycle) n = 76
Distance (4 Meter)	-0.08 (0.097)	-0.08 (0.100)
Intermediate (64 CM)	-0.02 (0.096)	-0.03 (0.095)
Near (40 CM)	0.04 (0.085)	0.02 (0.081)

Test (First Wearing Cycle): Least-square Mean: -0.084 (95% CI -0.124 to -0.044), Linear Mixed Model
Test (First Wearing Cycle): Least-square Mean: -0.028 (95% CI -0.068 to 0.012), Linear Mixed Model
Test (First Wearing Cycle): Least-square Means: 0.037 (95% CI -0.003 to 0.077), Linear Mixed Model

Population analysed: Subjects that completed all study visits without a major prtocol deviation impacting a primary endpoint

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the study. Approximately 1 month per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	1 of 86 (1.2%)	0 of 86 (0%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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

Related trials for Visual Acuity

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
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Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing ACUVUE® OASYS with Transitions™ in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 sites 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 18 May 2021). 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?

Vision Scores (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 NCT04073186.

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 10 Aug 2022.