Visual AcuityNCT03635528

Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control

A study testing Test Lens 1, Test Lens 2 and Test Lens 3 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 bilateral, non-dispensing, randomized, controlled, double-masked, 7x7 cross-over study. Each subject will be bilaterally fitted with one of the 7 test articles in each of the 7 periods for a total of four visits. Up to two lens types will be fit at each of the four study visits. Read more about this study

Who is it for?: Ages 7 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Test Lens 1, Test Lens 2 and Test Lens 3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 29 Nov 2018to 18 Jul 2019
Phase: Interventional
Are there results?: None posted in the registry

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 7 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Potential subjects must satisfy all following criteria to be enrolled in the study:
Pediatric subjects (<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must 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.
Between 7 and 25 years of age (inclusive).
Have normal eyes (i.e., no ocular medications or infections of any type).

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Vertex-corrected distance subjective best-sphere refraction must be between -0.75D and -5.00D (inclusive) in each eye.
Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
Have sphero-cylindrical best-corrected visual acuity of 20/25 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 systemic allergies, infectious disease (e.g., hepatitis, tuberculosis, HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. Specifically, any chronic (3 months or more) or short-term (within 7 days from enrollment) use of oral agents with antimuscarinic properties.
Any current use of ocular topical medication (occasional use of re-wetting drops is allowed). Specifically, any use of topical agents with anti-muscarinic properties within 21 days from enrollment.
Any previous or planned ocular or intraocular surgery, including refractive surgery.

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Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Current or recent (within 30 days from enrollment) rigid lens wearers.
History of orthokeratology treatment.
Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved equivalent) Rewetting Drop Solution.
Employees or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician).
Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.
Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
Any ocular abnormality that is contraindicated contact lens wear.
Any corneal scar within central 5mm
Binocular vision abnormality, intermittent strabismus or strabismus.
Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University, School of Optometry
Bloomington, Indiana, 47405

Other trials in United States

About this study

Conditions: Visual Acuity
Being tested: Test Lens 1, Test Lens 2, Test Lens 3, Test Lens 4, Test Lens 5

What participants receive

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

Test Lens 1Device
EMO-114
Test Lens 2Device
EMO-116
Test Lens 3Device
EMO-118
Test Lens 4Device
RMY-100
Test Lens 5Device
Biofinity multifocal D Lens
Control Lens 1Device
EMO-117
Control Lens 2Device
Proclear 1 day

Study groups in NCT03635528
Study group	Role	What they receive
Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5	Experimental	Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1	Experimental	Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2
Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2	Experimental	Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3; Device: Test Lens 4; Device: Test Lens 5; Device: Control Lens 1; Device: Control Lens 2

What is being measured

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

On-Axis Accommodative Response Method 1
On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with a wavefront aberrometer.
Measured: 10 minutes post-lens insertion
On-Axis Accommodative Response Method 2
On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with an open-field auto refractor.
Measured: 10 minutes post lens insertion

Secondary outcomes (2)

Off-Axis Wavefront Aberrations with Accomodation
Off-axis wavefront aberrations at ±10°, ±20°, ±30° retinal eccentricities with targets at 4 meters will be measured.
Measured: 10 minutes post-lens insertion
Off-Axis Wavefront Aberrations without Accomodation
Off-axis wavefront aberrations at ±30° retinal eccentricities with targets at 25 cm will be measured.
Measured: 10 minutes post lens insertion

Timeline

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

29 Nov 201818 Jul 2019

First posted17 Aug 2018
Study start29 Nov 2018
Primary completion18 Jul 2019
Study completion18 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03635528
Sponsor's protocol ID: CR-6008
Status last verified: Aug 2020
First submitted: 14 Aug 2018
Last updated: 20 Aug 2020
Results posted: No
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?

See locations

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control
ClinicalTrials.gov ID: NCT03635528
Acronym / sponsor ID: CR-6008
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 29 Nov 2018 (actual)
Primary completion: 18 Jul 2019 (actual)
Study completion: 18 Jul 2019 (actual)
First posted: 17 Aug 2018 (actual)
Results: Not posted in the source record

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: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 14

Arm	Type	Receives
Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2	Experimental	Device: Test Lens 1, Device: Test Lens 2, Device: Test Lens 3, Device: Test Lens 4, Device: Test Lens 5, Device: Control Lens 1, Device: Control Lens 2Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.

Who may qualify

Ages: 7 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (17 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
Test Lens 1EMO-114	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Test Lens 2EMO-116	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Test Lens 3EMO-118	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Test Lens 4RMY-100	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Test Lens 5Biofinity multifocal D Lens	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Control Lens 1EMO-117	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Control Lens 2Proclear 1 day	Device	Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3, Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2, Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3, Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4, Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4, Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5, Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5, Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1, Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1, Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2, Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2, Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1, Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2, Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1

Primary outcome

On-Axis Accommodative Response Method 1
Time frame: 10 minutes post-lens insertion
On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with a wavefront aberrometer.
On-Axis Accommodative Response Method 2
Time frame: 10 minutes post lens insertion
On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with an open-field auto refractor.

2 secondary outcomes

Off-Axis Wavefront Aberrations with Accomodation
Time frame: 10 minutes post-lens insertion
Off-Axis Wavefront Aberrations without Accomodation
Time frame: 10 minutes post lens insertion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Individual participant dataSharing planned: No

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Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration

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.

Xu Cheng study chair

Johnson & Johnson Vision Care, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens 1, Test Lens 2 and Test Lens 3 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 9 inclusion and 17 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 20 Aug 2020. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On-Axis Accommodative Response Method 1 (time frame: 10 minutes post-lens insertion). 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 NCT03635528.

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 20 Aug 2020.