AstigmatismNCT00581659
Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions
An observational study of Astigmatism, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects who currently wear spherical contact lenses and believe they have little or no astigmatism and are licensed drivers.
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
National Advanced Driving Simulator
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at the time of both drives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Timothy L. Brown, University of Iowa
- Investigators
- Mark Wilkinson, OD, Principal investigator, National Advanced Driving Simulator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581659
- Sponsor's protocol ID
- 200709761
- Status last verified
- Apr 2017
- First submitted
- 19 Dec 2007
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions
- ClinicalTrials.gov ID
- NCT00581659
- Acronym / sponsor ID
- 200709761
- Conditions
- Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Nov 2007 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects who currently wear spherical contact lenses and believe they have little or no astigmatism and are licensed drivers.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No. Individual data will not be shared
Related trials for Astigmatism
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wilkinson, OD principal investigator
National Advanced Driving Simulator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.