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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Driving Safety Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo, Spherical, then Toric Lenses; Crossover order 1	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Experimental: Placebo, Toric, then Spherical Lenses; Crossover order 2	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Experimental: Spherical, Placebo, then Toric Lenses; Crossover order 3	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Experimental: Spherical, Toric, then Placebo Lenses; Crossover order 4	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Experimental: Toric, Placebo, then Spherical Lenses; Crossover order 5	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Experimental: Toric, Spherical, then Placebo Lenses; Crossover order 6	Device: Placebo Lenses; AcuVue Oasys Bandage Lenses with no prescription; Device: Spherical Lenses; 1-DAY ACUVUE® MOIST contact lenses; Device: Toric Lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactical Composite Score	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operational Composite Score	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.	1 day

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Johnson & Johnson Vision Care, Inc.
• Investigators: Principal Investigator: Daniel J Cox, PhD, University of Virginia

Publications and helpful links

General Publications

• Cox DJ, Banton T, Record S, Grabman JH, Hawkins RJ. Does correcting astigmatism with toric lenses improve driving performance? Optom Vis Sci. 2015 Apr;92(4):404-11. doi: 10.1097/OPX.0000000000000554.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: astigmatism, contact lens, driving
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 18499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data and protocol will be shared on request.
• IPD Sharing Time Frame: Data will be available on request
• IPD Sharing Access Criteria: data will be shared via e-mail.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)