Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control
1 other identifier
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2019
CompletedAugust 20, 2020
August 1, 2020
8 months
August 14, 2018
August 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Off-Axis Wavefront Aberrations with Accomodation
10 minutes post-lens insertion
Off-Axis Wavefront Aberrations without Accomodation
10 minutes post lens insertion
Study Arms (14)
Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types.
Interventions
EMO-114
EMO-116
EMO-118
RMY-100
Biofinity multifocal D Lens
EMO-117
Proclear 1 day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University, School of Optometry
Bloomington, Indiana, 47405, United States
Study Officials
- STUDY CHAIR
Xu Cheng
Johnson & Johnson Vision Care, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 17, 2018
Study Start
November 29, 2018
Primary Completion
July 18, 2019
Study Completion
July 18, 2019
Last Updated
August 20, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share