Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control
August 18, 2020 updated by: Johnson & Johnson Vision Care, Inc.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Indiana University, School of Optometry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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).
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5
Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1
Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
|
Experimental: Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2
Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
|
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes post-lens insertion
|
|
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.
|
10 minutes post lens insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Off-Axis Wavefront Aberrations with Accomodation
Time Frame: 10 minutes post-lens insertion
|
Off-axis wavefront aberrations at ±10°, ±20°, ±30° retinal eccentricities with targets at 4 meters will be measured.
|
10 minutes post-lens insertion
|
|
Off-Axis Wavefront Aberrations without Accomodation
Time Frame: 10 minutes post lens insertion
|
Off-axis wavefront aberrations at ±30° retinal eccentricities with targets at 25 cm will be measured.
|
10 minutes post lens insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xu Cheng, Johnson & Johnson Vision Care, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2018
Primary Completion (Actual)
July 18, 2019
Study Completion (Actual)
July 18, 2019
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-6008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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