Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control

Conditions
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Visual Acuity

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention 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<br>Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1<br>Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|
| Experimental: Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2<br>Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. | Device: Test Lens 1<br>* EMO-114<br>Device: Test Lens 2<br>* EMO-116<br>Device: Test Lens 3<br>* EMO-118<br>Device: Test Lens 4<br>* RMY-100<br>Device: Test Lens 5<br>* Biofinity multifocal D Lens<br>Device: Control Lens 1<br>* EMO-117<br>Device: Control Lens 2<br>* Proclear 1 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 10 minutes post lens insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off-Axis Wavefront Aberrations with Accomodation | 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 | Off-axis wavefront aberrations at ±30° retinal eccentricities with targets at 25 cm will be measured. | 10 minutes post lens insertion |