Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions

NCT00581659 | Completed

• 1 other identifier: 200709761
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• The primary endpoint measured is the number of objects on the roadway that were detected - a count of the total number of objects that the driver correctly detects out of the total number of objects present.

  at time of both drives

Secondary Outcomes (1)

• 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.

  at the time of both drives

Study Arms (1)

Lens A, Lens B

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.

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who currently wear spherical contact lenses and believe they have little or no astigmatism and are licensed drivers.

You may qualify if:

• valid US driver's license
• drive at least 100 miles per month
• not restricted to driving at night
• willing to travel to the National Advanced Driving Simulator
• currently successfully wear soft spherical contact lenses
• between the ages of 25 and 45
• no previous participation in any vision simulator driving studies

You may not qualify if:

• known or suspected pregnancy
• current serious illness or have received radiation and/or chemotherapy treatment within the last 6 months
• Type 1 Diabetics or Untreated Type II Diabetics
• current heart condition or heart attack, or pacemaker implanted within last 6 months
• known seizure disorder or epilepsy
• Meniere's disease or any inner ear, vertigo, hearing, or balance conditions
• known narcolepsy
• Chronic Fatigue Syndrome
• untreated sleep apnea
• uncontrolled asthma or chronic bronchitis
• Chronic Obstructive Pulmonary Disease
• migraine headaches that require narcotic medications
• untreated depression or anxiety disorder
• claustrophobia
• drug dependency

Sponsors & Collaborators

• University of Iowa: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

National Advanced Driving Simulator

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mark Wilkinson, OD

  National Advanced Driving Simulator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)