Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions - Full Text View

Sponsored by:	National Advanced Driving Simulator
Information provided by:	National Advanced Driving Simulator
ClinicalTrials.gov Identifier:	NCT00581659

Purpose

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.

Condition
Astigmatism

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions

Further study details as provided by National Advanced Driving Simulator:

Primary Outcome Measures:

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. [ Time Frame: at time of both drives ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: at the time of both drives ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	24
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Groups/Cohorts

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.

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.

Eligibility

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

Inclusion Criteria:

Inclusion Criteria

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

Exclusion Criteria:

Exclusion Criteria

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
untreated ADHD
taking current prescription or over-the-counter medications that create sedation or drowsiness
uncontrolled glaucoma or glaucoma under current treatment
propensity toward motion sickness
new diagnosis of dementia by physician
diagnosis of macular degeneration
experience any side effects from dilation of the eyes
Diabetes-induced eye disease in either eye
Cataract surgery in either eye or currently have cataracts
refractive eye surgery in either eye
more than 0.25 diopters of refractive astigmatism in either eye
less than 0.05 microns of positive spherical aberration in either eye -refractive error less than -0.50 diopters or greater than -3.00 diopters -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581659

Contacts

Contact: Sue Ellen Salisbury, BS

(319) 335-4666

sueellen@nads-sc.uiowa.edu

Locations

United States, Iowa
National Advanced Driving Simulator	Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Mark Wilkinson, OD
Sub-Investigator: Timothy L Brown, PhD

Sponsors and Collaborators

National Advanced Driving Simulator

Investigators

Principal Investigator:

Mark Wilkinson, OD

National Advanced Driving Simulator

More Information

Responsible Party:	University of Iowa ( Dr. Mark Wilkinson )
Study ID Numbers:	N07-011a
Study First Received:	December 19, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00581659
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on January 13, 2009