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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P180035 / PAS001 |
| Date Original Protocol Accepted |
07/26/2021
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| Date Current Protocol Accepted |
06/09/2023
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| Study Name |
MiSight 1 Day PAS
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| Device Name |
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Child: 2-12 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.
Part 1 will study effectiveness of MiSight 1 Day in slowing myopia progression over three-years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.
Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.
The primary objectives of this study are:
(1) to confirm in the U.S. population that there are clinically meaningful differences (super-superiority margin of 0.50D) in the mean change of cycloplegic refractive error and axial length change from baseline after three years of using MiSight 1 Day lenses among intended patient population compared to the mean changes in a control group using conventional daily disposable lenses;
(2) to assess the stability of the myopia reduction over 1-year post-treatment among those who completed the 3-year confirmation study follow-up.
Secondary objectives of this study are:
(1) to estimate the effects of race, baseline cycloplegic spherical equivalent refractive error, and baseline age on the treatment effect;
(2) to assess the effects of the MiSight 1 Day on the patients’ visual symptoms and the effects on patients’ activities of daily living, using an appropriately validated patient-reported outcome (PRO) measure.
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| Study Population |
The eligible study population will be children ages of 8-12, who have best corrected visual acuity of at least 20/25 bilaterally with refractive error between -0.75 D to – 4.00D spherical equivalent and = 0.75 D of astigmatism at the initiation of treatment, who are free of ocular disease or abnormalities (including any corneal scar), who are not under medication that would interfere with contact lens wear or are using or have used any pharmaceuticals or other methods for control of myopia, and who have no other contraindications per product labeling.
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| Sample Size |
Part 1 will enroll a minimum of 675 patients in the MiSight 1 Day treatment group and 225 in the control group from all eligible patients in clinical sites and will have a target minimum of 664 total number of evaluable patients (498 patients in the treatment group and 166 patients in the control group) completing 3 years of wear.
All of those who completed the 3-year confirmation study follow-up will be continuously followed into Part 2. A target minimum number of 598 evaluable patients (with 448 in the treatment group and 150 in the control group) will complete this phase of the study
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| Key Study Endpoints |
The primary endpoints for Part 1 of this study are:
Mean difference in cycloplegic SERE change from baseline between the MiSight 1 Day group and control lens group after 3 years.
Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group after 3 years.
In addition, an estimate of the effects of race, baseline cycloplegic spherical equivalent refractive error, and baseline age on the treatment effect will be provided.
The primary endpoints for Part 2 of this study will be:
Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment.
Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.
Secondary endpoints for Part 1 of this study include:
A comparison of the rates of the patients’ visual symptoms and the effects on patients’ activities of daily living between the MiSight 1 Day and control lens groups using a validated PRO measure;
Comparison of percentage of subjects in the MiSight 1 Day group and control lens group with no appreciable myopic progression (-0.25D change or less) over the 3 years.
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| Follow-up Visits and Length of Follow-up |
Part 1: 3-year
Part 2: 1-year
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
206
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| Actual Number of Sites Enrolled |
22
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| Patient Follow-up Rate |
35 subjects (17%) have exited early. 23 did not meet enrollment criteria. 11 exited at lens fitting or follow up visits (e.g., poor fit, vision, comfort or difficulty with lens insertion and removal). 1 exited at 6 month visit due to lens discomfort.
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