Visual AcuityNCT02679976

Marketed Contact Lens Real World Through Focus Curve

A study testing etafilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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 years and olderHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2015to Aug 2015
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 ≥40 years of age.
The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
The subject's refractive cylinder must be ≤ -0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.
The subject must have best corrected visual acuity of 20/25 or better for each eye.
The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Who cannot join

Currently pregnant or lactating.
Any ocular or systemic allergies that contraindicate contact lens wear.
Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.
Any ocular abnormality that may interfere with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.
Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

Show all 14Show fewer

Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear.
History of herpetic keratitis.
Any ocular infection or inflammation.
Any corneal distortion or irregular cornea.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
History of diabetes.
Participant in unrelated research involving test product within 30 days before planned study visit.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Optometry Technology Group, Ltd.
London, SW1E 6AU

Other trials in United Kingdom

About this study

This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.

Conditions: Visual Acuity
Being tested: etafilcon A

What participants receive

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

etafilcon ADevice
Marketed Multifocal Contact Lens

Study groups in NCT02679976
Study group	Role	What they receive
Study Lens (etafilcon A) for Multifocal	Experimental	All Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes. Receives: Device: etafilcon A

What is being measured

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

Distance Binocular LogMAR Visual Acuity
Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Measured: 4 Hr. Post Fitting
Near Binocular LogMAR Visual Acuity
Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Measured: 4 Hr. Post Fitting
Intermediate Binocular LogMAR Visual Acuity
intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Measured: 4 Hr. Post Fitting

Timeline

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

Jul 2015Aug 2015

First posted11 Feb 2016 (estimated)
Study startJul 2015
Primary completionAug 2015
Study completionAug 2015

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679976
Sponsor's protocol ID: CR-5728
Status last verified: Jul 2016
First submitted: 22 Jan 2016
Last updated: 15 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

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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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
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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Marketed Contact Lens Real World Through Focus Curve
ClinicalTrials.gov ID: NCT02679976
Acronym / sponsor ID: CR-5728
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 11 Feb 2016 (estimated)
Results: Posted 15 Sep 2016

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
Study Lens (etafilcon A) for Multifocal	Experimental	Device: etafilcon AAll Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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 ≥40 years of age.
The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
The subject's refractive cylinder must be ≤ -0.75 D in each eye.

Key exclusion criteria (14 listed)

Currently pregnant or lactating.
Any ocular or systemic allergies that contraindicate contact lens wear.
Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.
Any ocular abnormality that may interfere with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.

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 AMarketed Multifocal Contact Lens	Device	Study Lens (etafilcon A) for Multifocal

Primary outcome

Distance Binocular LogMAR Visual Acuity
Time frame: 4 Hr. Post Fitting
Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Near Binocular LogMAR Visual Acuity
Time frame: 4 Hr. Post Fitting
Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Intermediate Binocular LogMAR Visual Acuity
Time frame: 4 Hr. Post Fitting
intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

Results and safety

Results posted to the registry on 15 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etafilcon A (Multi-focal)	30	30

Primary outcome: Distance Binocular LogMAR Visual Acuity

Time frame: 4 Hr. Post Fitting. Mean (Standard Deviation). Unit: -10*LogMAR

Measure	Etafilcon A (Multi-focal)- Hyperopes n = 16	Etafilcon A (Multi-focal)- Myopes n = 14
Low Luminance; N=16, N=14	-1.072 (0.8748)	-0.904 (1.1423)
Medium Luminance; N=16, N=14	0.9017 (0.450)	0.557 (0.9465)
High Luminance; N=16, N=14	1.488 (0.6960)	1.471 (1.650)

Population analysed: The analysis population includes all subjects that completed the study without a major protocol deviation.

Primary outcome: Near Binocular LogMAR Visual Acuity

Time frame: 4 Hr. Post Fitting. Mean (Standard Deviation). Unit: -10*LogMAR

Measure	Etafilcon A (Multi-focal)- Hyperopes n = 16	Etafilcon A (Multi-focal)- Myopes n = 14
Low Luminance; N=16, N=14	-2.278 (1.6989)	-2.261 (1.7030)
Medium Luminance; N=16, N=14	-0.591 (1.4003)	-0.650 (1.5274)
High Luminance; N=16, N=14	0.828 (0.9910)	0.786 (1.0480)

Population analysed: The analysis population includes all subjects that completed the study without a major protocol deviation.

Primary outcome: Intermediate Binocular LogMAR Visual Acuity

Time frame: 4 Hr. Post Fitting. Mean (Standard Deviation). Unit: -10*LogMAR

Measure	Etafilcon A (Multi-focal)- Hyperopes n = 16	Etafilcon A (Multi-focal)- Myopes n = 14
Low Luminance; N=16, N=14	-1.544 (1.0355)	-1.318 (1.4770)
Medium Luminance; N=16, N=14	-0.075 (0.8367)	0.043 (1.1410)
High Luminance; N=16, N=14	1.056 (0.7616)	1.157 (0.7037)

Population analysed: The analysis population includes all subjects that completed the study without a major protocol deviation.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A (Multi-focal)	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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 8 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 15 Sep 2016). 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 LogMAR Visual Acuity (time frame: 4 Hr. Post Fitting). The study lists 3 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 NCT02679976.

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 15 Sep 2016.