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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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Menicon RGP


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General
Study Status Terminated
Application Number /
Requirement Number		 P990018 S002/ PAS001
Date Original Protocol Accepted 07/12/2002
Date Current Protocol Accepted 07/12/2002
Study Name Menicon RGP
Device Name MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The PAS was designed as a prospective, multi-center (up to 200 investigational sites) epidemiological evaluation based upon 12 months data from a minimum of 5,000 subjects followed for up to 24 months. The protocol did not specify a hypothesis, however the main purpose of the study is to estimate the incidence of microbial keratitis.
Study Population Menicon Z tisilfocon A spherical aspheric non prism ballast toric and non prism ballast multifocal lenses are indicated for extended wear from 1 to 30 days between removals for cleaning and disinfection of the lenses as recommended by the eyecare professional for the correction of refractive error myopia hyperopia presbyopia and or astigmatism in non aphakic persons with non diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from 25.00 D to 25.00 D for daily wear and 25.00 D to 8.00 D for up to 30 days extended wear Toric
lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to 3.00 D of reading add power for up to 30 days extended wear. The study population is as per device indication
Sample Size 5000 subjects (both eyes), over 200 sites
Key Study Endpoints Any ulcerative and microbial keratitis on the cornea in the study population
Follow-up Visits and Length of Follow-up baseline, 6 m, 12 m, 18 m & 24 m
Interim or Final Data Summary
Interim Results Study was terminated. See final results
Actual Number of Patients Enrolled 507
Actual Number of Sites Enrolled 65
Patient Follow-up Rate 50%
Final Safety Findings No MK identified.
Study Strengths & Weaknesses Enrollment not met expectation, follow-up rate too low.
Recommendations for Labeling Changes Labeling was updated to reflect the results of the post-approval study.




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

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