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

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Lenses
Spherical Lenses
Toric Lenses
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, contact lens, driving

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Virginia Driving Safety Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

Crossover order 1

Crossover order 2

Crossover order 3

Crossover order 4

Crossover order 5

Crossover order 6

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2016
Last Updated
October 4, 2021
Sponsor
University of Virginia
Collaborators
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02950545
Brief Title
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Official Title
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
astigmatism, contact lens, driving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, Spherical, then Toric Lenses
Arm Type
Experimental
Arm Description
Crossover order 1
Arm Title
Placebo, Toric, then Spherical Lenses
Arm Type
Experimental
Arm Description
Crossover order 2
Arm Title
Spherical, Placebo, then Toric Lenses
Arm Type
Experimental
Arm Description
Crossover order 3
Arm Title
Spherical, Toric, then Placebo Lenses
Arm Type
Experimental
Arm Description
Crossover order 4
Arm Title
Toric, Placebo, then Spherical Lenses
Arm Type
Experimental
Arm Description
Crossover order 5
Arm Title
Toric, Spherical, then Placebo Lenses
Arm Type
Experimental
Arm Description
Crossover order 6
Intervention Type
Device
Intervention Name(s)
Placebo Lenses
Intervention Description
AcuVue Oasys Bandage Lenses with no prescription
Intervention Type
Device
Intervention Name(s)
Spherical Lenses
Intervention Description
1-DAY ACUVUE® MOIST contact lenses
Intervention Type
Device
Intervention Name(s)
Toric Lenses
Intervention Description
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Primary Outcome Measure Information:
Title
Tactical Composite Score
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Operational Composite Score
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Driving Safety Laboratory
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25946099
Citation
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.
Results Reference
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Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

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