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OpenTrials
Completed

NCT Number: NCT02950545

Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may experience blur while driving. The purpose of this study is to determine if correcting small amounts of astigmatism with contact lenses will improve driving safety.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Driving Safety Laboratory

Charlottesville, Virginia, 22908, United States

About this study

The purpose of this randomized control trial is to compare visual performance and simulated driving performance of adults with astigmatism when wearing 1*DAY ACUVUE® MOIST for ASTIGMATISM (toric), 1*DAY ACUVUE® MOIST (spherical control), and 1*DAY ACUVUE® MOIST (placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject will read letters on standard eye charts and complete vision and driving tests in a driving simulator. Subjects will repeat these tests with each lens type. Analyses will include an ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses under simulated driving conditions, which involve eye movement demands, will lend insight into the potential advantages of toric over spherical contact lenses for driving safety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult licensed driver
  • Ages 18-39 years
  • Corrected vision of 20/40 or better in each eye
  • Astigmatism between 0.75 and 1.75 diopters in each eye
  • Nearsightedness between 0 and -9 diopters in each eye
  • No active eye infection
  • No defective peripheral vision
  • No bifocal correction
  • Routinely wears toric contact lenses (more than 4 times per week)
  • Routinely drives a car (more than 4 times per week)
  • No history of motion, sea, or big screen (e.g. IMAX) sickness, and no persistent Simulation Adaptation Syndrome

Exclusion criteria

  • Corrected vision worse than 20/40 in either eye
  • No astigmatism in either eye
  • Active eye infection
  • Defective peripheral vision
  • Wears bifocals
  • Wears contact lenses less than 4 times per week
  • Drives infrequently (less than 4 times per week)

Treatment and study plan

Placebo Lenses

Device

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Device

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Device

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Primary outcomes

  1. Tactical Composite Score

    Time frame: 1 day

    This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.

Secondary outcomes

  1. Operational Composite Score

    Time frame: 1 day

    This scale measures driving-relevant visual performance. It is the sum of the z scores from 5 different driving simulator variables related to visual testing done in the simulator. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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