Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control
NCT ID: NCT03635528
Last Updated: 2020-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
11 participants
INTERVENTIONAL
2018-11-29
2019-07-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of Approved and Investigational Contact Lenses
NCT02669095
Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
NCT04968925
Clinical Evaluation of Approved Contact Lenses
NCT02699593
Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
NCT04709237
Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes
NCT04889625
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
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.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Test Lens 1
EMO-114
Test Lens 2
EMO-116
Test Lens 3
EMO-118
Test Lens 4
RMY-100
Test Lens 5
Biofinity multifocal D Lens
Control Lens 1
EMO-117
Control Lens 2
Proclear 1 day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 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.
2. 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.
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. Between 7 and 25 years of age (inclusive).
5. Have normal eyes (i.e., no ocular medications or infections of any type).
6. Vertex-corrected distance subjective best-sphere refraction must be between -0.75D and -5.00D (inclusive) in each eye.
7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
8. Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria
1. Currently pregnant or lactating.
2. 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.
3. 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.
4. 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.
5. Any previous or planned ocular or intraocular surgery, including refractive surgery.
6. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
7. Current or recent (within 30 days from enrollment) rigid lens wearers.
8. History of orthokeratology treatment.
9. Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved equivalent) Rewetting Drop Solution.
10. Employees or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician).
11. 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.
12. Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
13. Any ocular abnormality that is contraindicated contact lens wear.
14. Any corneal scar within central 5mm
15. Binocular vision abnormality, intermittent strabismus or strabismus.
16. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
7 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xu Cheng
Role: STUDY_CHAIR
Johnson & Johnson Vision Care, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University, School of Optometry
Bloomington, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR-6008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.