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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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MiSight 1 Day Safety PAS


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General
Study Status Progress Inadequate
Application Number P180035 / PAS002
Date Current Protocol Accepted  
Study Name MiSight 1 Day Safety PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Admin Database
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs
Detailed Study Protocol Parameters
Study Design Description 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.


Study Population Description 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.

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).

Data Collection 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.

Follow-up Visits and Length of Follow-up 3 years


MiSight 1 Day Safety PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 02/14/2020 02/13/2020 On Time
six month report 05/15/2020 05/13/2020 On Time
9 month report 08/14/2020 08/14/2020 On Time
one year report 11/14/2020 11/13/2020 On Time
18 month report 05/15/2021 05/14/2021 On Time
2 year report 11/14/2021 11/12/2021 On Time
enrollment report 02/16/2022 02/16/2022 On Time
enrollment report 05/14/2022 05/13/2022 On Time
enrollment report 08/08/2022 08/08/2022 On Time
3 year report 11/14/2022    
4 year report 11/14/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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