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FDA Study Summary of Safety and Effectiveness, Premarket Approval Application (PMA) Number: P0 10062
iGO SYNOPSIS: Medical devices like contact lenses are subject to approval by the US Food and Drug Administration (FDA) before they can be prescribed or sold commercially over-the-counter to the general public. The FDA approval is dependent on the outcome of a clinical trial where the devices are assessed in terms of their safety and whether they deliver the claimed performance benefits. In the case of i-GO OVC lenses, the FDA approval was granted in June 2004 following a two year trial involving almost 200 people ranging in age from 18 to 62 with varying levels of short-sightedness up to -5.00D. Of those participants who completed the trial, 99% were shown to have experienced a reduction in their level of short-sightedness as measured at the start of the trial, with 95% demonstrating an achieved visual acuity of 20/40 or better. No adverse safety issues were identified other than a small number of minor problems evident with 10 participants which are frequently associated with standard contact lens wear.
ABSTRACT: The main objective of this study was to assess the safety and effectiveness of the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses in the temporary
reduction of myopia, when worn overnight. This investigation was a multi-center study consisting of 9 investigational sites
which included 14 investigators participating. The study was initiated on
September 21, 1998 and ended on June 2, 2000. There were 191 patients (378
eyes) enrolled into the study including 4 monocular subjects. There were 4
ineligible eyes enrolled but not dispensed lenses. The subjects were at least 18
years old.
Clinical investigators and investigational sites were selected in an effort to provide sufficient diversity in geographic access, climate and elevation, and urban and rural living for a resultant study population that represents the intended
population to be treated. The study period was 9 months
RESULTS: The results of the data provided from this clinical study revealed no major complications or slit lamp findings and 12 adverse events which resolved. Additionally, the results show that 95 % of the eyes completing the study in the core group achieved visual acuity of 20/40 or better at nine months and 99% demonstrated a reduction in pretreatment myopia.
The results of the clinical study provide reasonable
assurance of the safety and effectiveness of the device for the subject population, refractive conditions and specified wearing modality.
June 7, 2004 Federal Drugs Agency of America www.fda.gov
