Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Advanced Driving Simulator.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Advanced Driving Simulator
ClinicalTrials.gov Identifier:
NCT00581659
First received: December 19, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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

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

Resource links provided by NLM:


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 ]

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2014