Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 3:01 PM
Ignite Modification Date: 2025-12-24 @ 3:01 PM
NCT ID: NCT00581659
Brief Summary: The objective of this study is to quantify differences in nighttime driving performance between the Bausch \& Lomb PureVision™ aspheric contact lenses and a conventional spherical contact lens. The primary aims of this study are to determine the differences between B\&L PureVision™ aspheric contact lenses and a conventional spherical contact lens in visual performance measures associated with driving, such as number of objects seen. The secondary aims of this study are to determine differences between B\&L PureVision™ aspheric contact lenses and a conventional spherical contact lens in driving performance measures such as number of objects hit.
Detailed Description: Contact lenses have the potential to affect visual performance in various driving situations, including low-visibility situations such as driving at night. This study will assess the effect on typical nighttime driving tasks such as reading signs and avoiding road hazards. This is a single-site study. Individuals who are currently spherical contact lens wearers, who believe they have little or no astigmatism, and who are licensed drivers will be invited to partipate in this study. Twenty-four completed subjects are required. This study will involve a 2x2 within-subject comparison. The first independent variable is the contact lens. Each subject will wear both PureVision (TM0 aspheric contact lenses and conventional spherical contact lenses on separate visits. The second independent variable is visibility condition. Subjects will complete the study drive both in clear nighttime conditions and at night under glare conditions. In both cases, the driver will experience oncoming traffic; however, in the glare condition, the simulator will be equipped with a point light source sufficient to provide glare similar to that provided by oncoming traffic in the real world.
Study: NCT00581659
Study Brief:
Protocol Section: NCT00581659