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Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions

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ClinicalTrials.gov Identifier: NCT00581659
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Astigmatism

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 Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions
Actual Study Start Date : November 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: at time of both drives ]

Secondary Outcome Measures :
  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. [ Time Frame: at the time of both drives ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581659


Locations
United States, Iowa
National Advanced Driving Simulator
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Mark Wilkinson, OD National Advanced Driving Simulator
More Information

Responsible Party: Timothy L. Brown, Associate Research Scientist, University of Iowa
ClinicalTrials.gov Identifier: NCT00581659     History of Changes
Other Study ID Numbers: 200709761
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases