Visual AcuityNCT05000164

Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens

A study testing Bausch + Lomb Ultra® Multifocal for Astigmatism in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 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

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses. 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?: Bausch + Lomb Ultra® Multifocal for Astigmatism
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 9 sitesUnited States
Study dates: 2 Aug 2021to 13 Jan 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 40 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.
Be at least 40 and not more than 70 years of age at the time of screening.
Own a wearable pair of spectacles if required for their distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past month).

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Be an existing wearer of a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in each eye.
Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder axis 90°±25°.
Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye.
Have best corrected distance visual acuity of 20/20-3 or better in each eye.

Who cannot join

The subject must not:
Be currently pregnant or lactating.
Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Have 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, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications.
Currently use ocular medication with the exception of rewetting drops.

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Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, sodium fluorescein, or Biotrue® multipurpose solution.
Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
Have a history of amblyopia or strabismus.
Have a history of herpetic keratitis.
Have a history of irregular cornea.
Have a history of pathological dry eye.
Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
Have any current ocular infection or inflammation.
Have any current ocular abnormality that may interfere with contact lens wear.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

The Eyecare Studio
Decatur, Georgia, 13850
Vision Boutique
Houston, Texas, 77005
Vue Optical Boutique
Jacksonville, Florida, 32205
Stam & Associates Eye Care
Jacksonville, Florida, 32256
VRC-East
Jacksonville, Florida, 32256
Maitland Vision Center
Maitland, Florida, 32751
Ctr For Opht and Vision Rsrch At Eye Associates Of New York
Manhattan, New York, 10222
Botetourt Eyecare LLC
Salem, Virginia, 24153
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

About this study

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Read the detailed description

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Conditions: Visual Acuity
Being tested: Bausch + Lomb Ultra® Multifocal for Astigmatism

What participants receive

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

Bausch + Lomb Ultra® Multifocal for AstigmatismDevice
Study Lens

Study groups in NCT05000164
Study group	Role	What they receive
Market Product	Experimental	Eligible subjects will be dispensed the study lenses in a bilateral fashion and will be in the treatment for approximately 5 weeks. Receives: Device: Bausch + Lomb Ultra® Multifocal for Astigmatism

What is being measured

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

Binocular High Luminance High Contrast logMAR Visual Acuity
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling 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: 4-Week Follow-up

Timeline

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

2 Aug 202113 Jan 2022

First posted11 Aug 2021
Study start2 Aug 2021
Primary completion13 Jan 2022
Study completion13 Jan 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05000164
Sponsor's protocol ID: CR-6383
Status last verified: Jan 2023
First submitted: 3 Aug 2021
Last updated: 23 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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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens
ClinicalTrials.gov ID: NCT05000164
Acronym / sponsor ID: CR-6383
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 2 Aug 2021 (actual)
Primary completion: 13 Jan 2022 (actual)
Study completion: 13 Jan 2022 (actual)
First posted: 11 Aug 2021 (actual)
Results: Posted 23 Jan 2023

Clinical summary

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

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Detailed description

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Study design

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

Arm	Type	Receives
Market Product	Experimental	Device: Bausch + Lomb Ultra® Multifocal for AstigmatismEligible subjects will be dispensed the study lenses in a bilateral fashion and will be in the treatment for approximately 5 weeks.

Who may qualify

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

Key inclusion criteria (11 listed)

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

Key exclusion criteria (18 listed)

The subject must not:

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
Bausch + Lomb Ultra® Multifocal for AstigmatismStudy Lens	Device	Market Product

Primary outcome

Binocular High Luminance High Contrast logMAR Visual Acuity
Time frame: 4-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling 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.

Results and safety

Results posted to the registry on 23 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
Samfilcon A	72	62

Primary outcome: Binocular High Luminance High Contrast logMAR Visual Acuity

Time frame: 4-Week Follow-up. Mean (Standard Deviation). Unit: LogMAR

Measure	Samfilcon A n = 62
Distance (4m)	-0.13 (0.097)
Intermediate (64cm)	-0.02 (0.115)
Near (40cm)	0.09 (0.139)

Samfilcon A: Least-square Mean: -0.12 (95% CI -0.17 to -0.07), Mixed Models Analysis
Samfilcon A: Least-square Mean: -0.01 (95% CI -0.06 to 0.04), Mixed Models Analysis
Samfilcon A: Least-square Mean: 0.09 (95% CI 0.04 to 0.15), Mixed Models Analysis

Population analysed: All completed subjects.

Adverse events

Time frame: Throughout the 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
Samfilcon A	0 of 72 (0%)	0 of 72 (0%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 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

Related trials for Visual Acuity

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Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
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Recruiting
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Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
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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.

Johnson & Johnson Vision Care, Inc. Clinical Trial study director

Johnson & Johnson Vision Care, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Bausch + Lomb Ultra® Multifocal for Astigmatism in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 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 11 inclusion and 18 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 23 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 9 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 23 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?

Binocular High Luminance High Contrast logMAR Visual Acuity (time frame: 4-Week Follow-up). 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 NCT05000164.

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 23 Jan 2023.