Visual PerformanceNCT03322423

Evaluation of Two Marketed Multifocal Contact Lenses

A study testing Multifocal Contact Lens 1, Multifocal Contact Lens 2 and Spherical Contact Lens 2 in people with Visual Performance, 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, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal 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 Performance
What is being tested?: Multifocal Contact Lens 1, Multifocal Contact Lens 2 and Spherical Contact Lens 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 5 sitesUnited States
Study dates: 11 Sep 2017to 4 Nov 2017
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:
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 at least 40 years of age and not greater than 70 years of age.
The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
The subject's refractive cylinder must be ≤ -0.75 D in each eye.

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The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
The subject must own a pair of wearable spectacles if required for their distance vision.
The subject must be an adapted 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 or more duration).
The subject must either be wearing 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".

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
Pregnancy or lactation.
Currently diagnosed with diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
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.

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Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
A history of amblyopia, strabismus or binocular vision abnormality.
Any ocular infection or inflammation.
Any ocular abnormality that may interfere with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.
History of herpetic keratitis.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

ABQ Eye Care
Albuquerque, New Mexico, 87109
Botetourt Eyecare, LLC
Salem, Virginia, 24153
Golden Vision
Sarasota, Florida, 34232
Sacco Eye Group
Vestal, New York, 13850
West Bay Eye Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Conditions: Visual Performance
Being tested: Multifocal Contact Lens 1, Multifocal Contact Lens 2, Spherical Contact Lens 2

What participants receive

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

Multifocal Contact Lens 1Device
Also called Test 1 Multifocal , delefilcon A
Dailies Total 1 Multifocal Contact Lens
Multifocal Contact Lens 2Device
Also called Test 2 Multifocal, nesofilcon A
Biotrue ONEday for Presbyopia Contact Lenses
Spherical Contact Lens 2Device
Also called Test 2 Alternative, nesofilcon A
BioTrue ONEDay Spherical

Study groups in NCT03322423
Study group	Role	What they receive
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative	Active comparator	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period. Receives: Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2; Device: Spherical Contact Lens 2
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal	Active comparator	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period. Receives: Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2; Device: Spherical Contact Lens 2

What is being measured

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

Distance Binocular Visual Acuity
Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Measured: 1-Week Follow-up
Near Binocular Visual Acuity
Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.
Measured: 1-Week Follow-up

Secondary outcomes (1)

Overall Quality of Vision
Overall quality of 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.
Measured: 1-Week Follow-up

Timeline

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

11 Sep 20174 Nov 2017

First posted26 Oct 2017
Study start11 Sep 2017
Primary completion4 Nov 2017
Study completion4 Nov 2017

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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03322423
Sponsor's protocol ID: CR-5860
Status last verified: Dec 2018
First submitted: 28 Sep 2017
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Two Marketed Multifocal Contact Lenses
ClinicalTrials.gov ID: NCT03322423
Acronym / sponsor ID: CR-5860
Conditions: Visual Performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 11 Sep 2017 (actual)
Primary completion: 4 Nov 2017 (actual)
Study completion: 4 Nov 2017 (actual)
First posted: 26 Oct 2017 (actual)
Results: Posted 8 Jan 2019

Clinical summary

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

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative	Active comparator	Device: Multifocal Contact Lens 1, Device: Multifocal Contact Lens 2, Device: Spherical Contact Lens 2Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal	Active comparator	Device: Multifocal Contact Lens 1, Device: Multifocal Contact Lens 2, Device: Spherical Contact Lens 2Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.

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 (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
Multifocal Contact Lens 1Also: Test 1 Multifocal , delefilcon ADailies Total 1 Multifocal Contact Lens	Device	Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative, Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Multifocal Contact Lens 2Also: Test 2 Multifocal, nesofilcon ABiotrue ONEday for Presbyopia Contact Lenses	Device	Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative, Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Spherical Contact Lens 2Also: Test 2 Alternative, nesofilcon ABioTrue ONEDay Spherical	Device	Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative, Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

Primary outcome

Distance Binocular Visual Acuity
Time frame: 1-Week Follow-up
Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Near Binocular Visual Acuity
Time frame: 1-Week Follow-up
Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.

1 secondary outcome

Overall Quality of Vision
Time frame: 1-Week Follow-up

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delefilcon A/Nesofilcon A	38	36
Nesofilcon A/Delefilcon A	40	38

Primary outcome: Distance Binocular Visual Acuity

Time frame: 1-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Delefilcon A n = 65	Nesofilcon A n = 65
Value	-0.056 (0.0842)	-0.075 (0.0759)

Delefilcon A: Least-Square Mean Estimate: -0.058 (95% CI -0.080 to -0.035), Linear mixed model analysis
Nesofilcon A: Least-Square Mean Estimate: -0.076 (95% CI -0.099 to -0.054), Linear mixed model analysis

Population analysed: All subjects that completed all study visits without a major protocol deviation.

Primary outcome: Near Binocular Visual Acuity

Time frame: 1-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Delefilcon A n = 65	Nesofilcon A n = 65
Value	0.143 (0.1084)	0.143 (0.1117)

Delefilcon A: LS Mean Estimate: 0.141 (95% CI 0.112 to 0.170), Linear mixed model analysis
Nesofilcon A: LS Mean Estimate: 0.141 (95% CI 0.112 to 0.170), Linear mixed model analysis

Population analysed: All subjects that completed all study visits without a major protocol deviation.

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
Delefilcon A	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Nesofilcon A	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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?

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 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 8 Jan 2019. 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 8 Jan 2019). 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?

Distance Binocular Visual Acuity (time frame: 1-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 NCT03322423.

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 8 Jan 2019.