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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P180035 / PAS002 |
| Date Original Protocol Accepted |
07/12/2021
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| Date Current Protocol Accepted |
06/09/2023
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| Study Name |
MiSight 1 Day Safety 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 |
Prospective Cohort Study
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| Data Source |
Admin Database
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| Comparison Group |
Objective Performance Criterion
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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 |
PAS002 is a cohort study nested within integrated (optometry / ophthalmology) eyecare practices or integrated health care and coverage organization systems. Consecutive subjects who are fitted in the MiSight1 Day lens, and who meet the product indication inclusion criteria, will be prospectively offered to participate in the study. Subsequent occurrence of the outcomes of interest will be identified via active adverse event reporting via Case Report Forms from investigative sites, an on-site survey at routine biannual visits, and release of medical records from all medical practitioners associated with management of any adverse event.
The primary objectives of this study is to confirm that the incidence of Microbial Keratitis (MK) is lower than 0.002/patient-year among the intended patient population in the US.
The secondary objective of this study is to determine the incidence rate of the following safety data among the intended patient population of the MiSight 1-Day lens in the US:
(1) the incidence of peripheral infiltrative keratitis/non-infectious ulcers,
(2) the incidence of non-infectious infiltrative keratitis,
(3) the incidence of loss of best-corrected visual acuity greater than or equal to 2 lines for any adjudicated adverse event.
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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 less than or equal to 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.
Only children first fitted in MiSight 1 Day lenses after the date of study initiation at the clinical site are eligible to participate in the study.
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| Sample Size |
To estimate the microbial keratitis rate, accrual of 8,500 patient-years is needed. A minimum of 6,000 patient-years, from approximately 2,000 prospectively identified subjects will be accumulated from this safety PAS, and a minimum of 2,500 patient-years will be accumulated from the subjects enrolled in PAS001 protocol (MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms).
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| Key Study Endpoints |
The primary endpoint for the study is:
the incidence rate of contact lens-related microbial keratitis based on the number of adjudicated cases of “Probable microbial keratitis” related to contact lens wear.
Secondary endpoints for the study are:
the incidence rate of peripheral infiltrative keratitis/non-infectious ulcers based on the number of adjudicated cases of “Peripheral infiltrative keratitis/ Probable non-infectious ulcer”.
the incidence rate of non-infectious infiltrative keratitis based on the number of adjudicated cases of “Probable non-infectious infiltrative keratitis”.
the incidence rate of loss of best-corrected visual acuity of greater than or equal to 2 lines for any adjudicated adverse event.
These additional endpoints will also be ascertained:
Patient/Parent/Guardian declining participation in the study and reasons for declining
Percentage of subjects discontinuing lens wear and reasons
Percentage subjects lost-to-follow-up.
An Endpoint Adjudication Committee (EAC) will be formed in association with this study to adjudicate diagnosis of adverse events. The EAC will include five (5) ophthalmologist clinicians/researchers experienced in the diagnosis and management of contact lens-related microbial keratitis, 3 active members and 2 alternates to assure continuity over the multi-year progress of the study.
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
120
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| Actual Number of Sites Enrolled |
34
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| Patient Follow-up Rate |
A total of 120 children were consented and enrolled. Seven children exited the study early (five at the initial visit, two before the 6-month visit due to discontinuing wear of MiSight 1 day). One site consented a 13-year-old; the subject was flagged in the electronic data capture and exited with no other data recorded.
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