Visual AcuityNCT03208088

Clinical Evaluation of Multifocal Toric Contact Lenses

A study testing etafilcon A Investigational Toric Multifocal Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: etafilcon A Investigational Toric Multifocal Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 7 sitesUnited States
Study dates: 12 Jun 2017to 21 Jul 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 40 and 70 years of age.
The subject's distance refraction must be in the range of -1.50 D to -4.50 D.
The subject's refractive cylinder must be -1.00 to -1.50 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
Subjects must own a wearable pair of spectacles if required for their distance vision
The subject must be an adapted soft contact lens wearer in both eyes (ie, 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 already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".

Who cannot join

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 (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, 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
Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions

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Any previous, or planned, ocular or intraocular surgery (eg, 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 (eg, Investigator, Coordinator, Technician).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Spectrum Eyecare
Jamestown, New York, 14750
Lee & Leong Doctors of Optometry
Kahului, Hawaii, 96732
Optometry Group, PLLC
Memphis, Tennessee, 38111
Miamisburg Vision Care
Miamisburg, Ohio, 45342
Bay Hill Eye Care
Orlando, Florida, 32819
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Conditions: Visual Acuity
Being tested: etafilcon A Investigational Toric Multifocal Contact Lens

What participants receive

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

etafilcon A Investigational Toric Multifocal Contact LensDevice
Test Lens 1
etafilcon A Investigational Toric Multifocal Contact LensDevice
Test Lens 2
etafilcon A Investigational Toric Multifocal Contact LensDevice
Tes Lens 3
etafilcon A Investigational Toric Multifocal Contact LensDevice
Test Lens 4
etafilcon A Investigational Toric Multifocal Contact LensDevice
Control Lens

Study groups in NCT03208088
Study group	Role	What they receive
Sequence 1	Experimental	etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 2	Experimental	etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 3	Experimental	etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 4	Experimental	etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 5	Experimental	etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 6	Experimental	etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 7	Experimental	etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 8	Experimental	etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 9	Experimental	etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens
Sequence 10	Experimental	etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator) Receives: Device: etafilcon A Investigational Toric Multifocal Contact Lens

What is being measured

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

Overall Handling Comparison Between Test 1/Test 2 and Control
Overall handling 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: 15 minutes

Secondary outcomes (1)

Overall Handling Comparison Between Test 3/Test 4 and Control
Overall handling 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: 15 minutes

Timeline

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

12 Jun 201721 Jul 2017

First posted5 Jul 2017
Study start12 Jun 2017
Primary completion21 Jul 2017
Study completion21 Jul 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 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03208088
Sponsor's protocol ID: CR-5935
Status last verified: Aug 2020
First submitted: 30 Jun 2017
Last updated: 10 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Multifocal Toric Contact Lenses
ClinicalTrials.gov ID: NCT03208088
Acronym / sponsor ID: CR-5935
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 12 Jun 2017 (actual)
Primary completion: 21 Jul 2017 (actual)
Study completion: 21 Jul 2017 (actual)
First posted: 5 Jul 2017 (actual)
Results: Posted 10 Sep 2020

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Sequence 1	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental)
Sequence 2	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator)
Sequence 3	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental)
Sequence 4	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental)
Sequence 5	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental)
Sequence 6	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental)
Sequence 7	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental)
Sequence 8	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental)
Sequence 9	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental)
Sequence 10	Experimental	Device: etafilcon A Investigational Toric Multifocal Contact Lensetafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator)

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 (14 listed)

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 (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, 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

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
etafilcon A Investigational Toric Multifocal Contact LensTest Lens 1	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
etafilcon A Investigational Toric Multifocal Contact LensTest Lens 2	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
etafilcon A Investigational Toric Multifocal Contact LensTes Lens 3	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
etafilcon A Investigational Toric Multifocal Contact LensTest Lens 4	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
etafilcon A Investigational Toric Multifocal Contact LensControl Lens	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9

Primary outcome

Overall Handling Comparison Between Test 1/Test 2 and Control
Time frame: 15 minutes
Overall handling 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.

1 secondary outcome

Overall Handling Comparison Between Test 3/Test 4 and Control
Time frame: 15 minutes

Results and safety

Results posted to the registry on 10 Sep 2020, 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 3/Test 2/Test 4/Test 1/Control	10	10
Test 3/Test 4/Test 2/Control/Test 1	9	9
Test 1/Control/Test 2/Test 4/Test 3	10	10
Test 1/Test 2/Control/Test 3/Test 4	9	9
Control/Test 1/Test 4/Test 2/Test 3	9	9
Control/Test 4/Test 1/Test 3/Test 2	9	9
Test 2/Test 3/Test 1/Test 4 /Control	8	8
Test 2/Test 1/Test 3/Control/Test 4	10	10
Test 4/Test 3/Control/Test 2/Test 1	8	8
Test 4/Control/Test 3/Test 1/Test 2	9	9

Primary outcome: Overall Handling Comparison Between Test 1/Test 2 and Control

Time frame: 15 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Test 1 n = 67	Test 2 n = 67	Control n = 67
Value	57.1 (21.34)	53.3 (22.47)	52.3 (23.88)

Test 1 vs Control: Least Square Mean Difference: 5.9 (95% CI 0.1 to 11.6), Mixed Models Analysis
Test 2 vs Control: Least Square Mean Difference: 2.1 (95% CI -4.0 to 8.1), Mixed Models Analysis

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

1 secondary outcome is reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Test 1	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Test 2	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Test 3	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Test 4	0 of 89 (0%)	0 of 89 (0%)	0 of 89
Control	0 of 90 (0%)	0 of 90 (0%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A Investigational Toric Multifocal Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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 14 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 10 Sep 2020). 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?

Overall Handling Comparison Between Test 1/Test 2 and Control (time frame: 15 minutes). 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 NCT03208088.

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 Sep 2020.