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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980006 S004/ PAS001 |
| Date Original Protocol Accepted |
11/20/2001
|
| Date Current Protocol Accepted |
|
| Study Name |
Long Term
|
| Device Name |
PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
An open-label post-market surveillance study designed to assess the occurrence of serious adverse events with the Bausch and Lomb PureVision Contact Lens when worn on a 30-day continuous wear basis. A serious adverse event (for this study) was considered to be any case of microbial keratitis or a loss of more than two lines of best corrected (spherocylindrical refractive) visual acuity. The study was divided into two phases: Phase 1 represented the first 12 months of lens wear; Phase 2 was optional and represented the duration of wear time for each subject following completion of Phase 1. The maximum length of Phase 2 was three years. In both phases, each subject wore PureVision Contact Lenses on each eye on a 30-day continuous wear basis. Lenses were worn overnight without removal for 22-29 consecutive nights, and were removed and replaced with new lenses on the morning of the 30th day.
|
| Study Population |
This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The study population is as per indication.
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| Sample Size |
6500, minimal 100 sites
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| Key Study Endpoints |
Development of microbial keratitis, and reduction in best corrected VA of more than two lines
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| Follow-up Visits and Length of Follow-up |
The study was divided into two phases: Phase 1 lasted for approximately 12 months; Phase 2 was considered optional and consisted of the duration of time a subject was in PureVision lenses following completion of Phase 1. The maximum length of Phase 2 was 3 years. [Note: An amendment was approved by the US FDA approximately two years after study initiation. This amendment divided the study into 2 phases, allowing for continued follow-up (in Phase 2) of enrolled subjects beyond the original 12 month study period (after completion of Phase 1).] Date first subject enrolled: 22 Mar 2002; Date last subject exited: 14 Dec 2006
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