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

NCT02950545 | Completed Results

• 1 other identifier: 18499
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Astigmatism

Keywords

astigmatism, contact lens, driving

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Operational Composite Score

  1 day

Study Arms (6)

Placebo, Spherical, then Toric Lenses

EXPERIMENTAL

Crossover order 1

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Placebo, Toric, then Spherical Lenses

EXPERIMENTAL

Crossover order 2

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Spherical, Placebo, then Toric Lenses

EXPERIMENTAL

Crossover order 3

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Spherical, Toric, then Placebo Lenses

EXPERIMENTAL

Crossover order 4

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Toric, Placebo, then Spherical Lenses

EXPERIMENTAL

Crossover order 5

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Toric, Spherical, then Placebo Lenses

EXPERIMENTAL

Crossover order 6

Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses

Interventions

Placebo Lenses DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Placebo, Spherical, then Toric Lenses; Placebo, Toric, then Spherical Lenses; Spherical, Placebo, then Toric Lenses; Spherical, Toric, then Placebo Lenses; Toric, Placebo, then Spherical Lenses; Toric, Spherical, then Placebo Lenses

Spherical Lenses DEVICE

1-DAY ACUVUE® MOIST contact lenses

Placebo, Spherical, then Toric Lenses; Placebo, Toric, then Spherical Lenses; Spherical, Placebo, then Toric Lenses; Spherical, Toric, then Placebo Lenses; Toric, Placebo, then Spherical Lenses; Toric, Spherical, then Placebo Lenses

Toric Lenses DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Placebo, Spherical, then Toric Lenses; Placebo, Toric, then Spherical Lenses; Spherical, Placebo, then Toric Lenses; Spherical, Toric, then Placebo Lenses; Toric, Placebo, then Spherical Lenses; Toric, Spherical, then Placebo Lenses

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead
• Johnson & Johnson Vision Care, Inc.: collaborator

Study Sites (1)

University of Virginia Driving Safety Laboratory

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 25946099 BACKGROUND

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

The study primarily investigated vehicle control. Object recognition is also a critical aspect of driving, but was not fully investigated in this study.

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Virginia

djc4f@virginia.edu

434-924-8021

Study Officials

• Daniel J Cox, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 6, 2021
• Results First Posted: April 21, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available on request
• Access Criteria: data will be shared via e-mail.

Locations

US (1)