CUMULATIVE EXPERIENCE OF EXTENDED WEAR CLINICAL TRIALS OF A SILICONE HYDROGEL CONTACT LENS

Frederick Edmunds

Abstract

PURPOSE. The launch of silicone hydrogel contact lenses has ushered in a new era of extended wear. Eye care practitioners, as well as potential wearers have approached this previously popular modality with caution based on the historical record and negative perceptions of extended wear with conventional hydrogel lenses. A key concern of the profession regarding this modality is incidence of microbial keratitis (MK). The purpose of this poster is to report the cumulative experience of controlled extended wear clinical trials for PureVision (balafilcon A) contact lenses with regard to patient-years and incidence of sight threatening adverse events (e.g. MK). METHOD. The results of 27 extended wear studies with Bausch & Lomb’s PureVision (balafilcon A) silicone hydrogel lens were reviewed and analyzed for cumulative wearing experience and serious adverse events including MK.

RESULTS. Over 4,700 patients have completed 27 extended wear studies. These studies ranged in length from 2 weeks to 1.5 years, and provide over 2200 patient-years of data. There were no reports of MK or other sight-threatening adverse events. Other clinical signs were within expected norms.

CONCLUSIONS. Based on the conclusion of the Contact Lens Institute (CLI) study, and on the number of patient-years (>2,200) accumulated in our extended wear clinical trials, one would estimate that five events of MK would have been observed. While an incidence rate of MK has not yet been established, these clinical finding suggest that the incidence of MK or other sight-threatening events, will be less than that reported in the landmark CLI study of conventional hydrogel lenses.

Details

Year: 2001

Program Number: Poster 132

Author Affiliation: Bausch & Lomb, Inc.

Co-Authors: Timothy Comstock, Thomas Crescuillo, William Reindel

Co-Author Affiliation: Bausch & Lomb, Inc., Bausch & Lomb, Bausch & Lomb, Inc.

Room: Poster 132