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

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT02950545
Collaborator
Johnson & Johnson Vision Care, Inc. (Industry)
51
Enrollment
1
Location
6
Arms
10.1
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Placebo Lenses
  • Device: Spherical Lenses
  • Device: Toric Lenses
N/A

Detailed Description

The purpose of this randomized control trial is to compare visual performance and simulated driving performance of adults with astigmatism when wearing 1DAY ACUVUE® MOIST for ASTIGMATISM (toric), 1DAY 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 Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Tactical Composite Score [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 Outcome Measures

  1. Operational Composite Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Virginia Driving Safety LaboratoryCharlottesvilleVirginiaUnited States22908

Sponsors and Collaborators

  • University of Virginia
  • Johnson & Johnson Vision Care, Inc.

Investigators

  • Principal Investigator: Daniel J Cox, PhD, University of Virginia

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier:
NCT02950545
Other Study ID Numbers:
  • 18499
First Posted:
Nov 1, 2016
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleCrossover Order 1Crossover Order 2Crossover Order 3Crossover Order 4Crossover Order 5Crossover Order 6
Arm/Group DescriptionPlacebo, Spherical, then Toric lensesPlacebo, Toric, then Spherical lensesSpherical, Placebo, then Toric lensesSpherical, Toric, then Placebo lensesToric, Placebo, then Spherical lensesToric, Spherical, then Placebo lenses
Period Title: Session 1 (70 Minutes)
STARTED9978810
COMPLETED997889
NOT COMPLETED000001
Period Title: Session 1 (70 Minutes)
STARTED997889
COMPLETED897788
NOT COMPLETED100101
Period Title: Session 1 (70 Minutes)
STARTED897788
COMPLETED897778
NOT COMPLETED000010
Period Title: Session 1 (70 Minutes)
STARTED897778
COMPLETED797778
NOT COMPLETED100000
Period Title: Session 1 (70 Minutes)
STARTED797778
COMPLETED797777
NOT COMPLETED000001

Baseline Characteristics

Arm/Group TitleCrossover Order 1Crossover Order 2Crossover Order 3Crossover Order 4Crossover Order 5Crossover Order 6Total
Arm/Group DescriptionPlacebo, Spherical, Then Toric LensesPlacebo, Toric, Then Spherical LensesSpherical, Placebo, Then Toric LensesSpherical, Toric, Then Placebo LensesToric, Placebo, Then Spherical LensesToric, Spherical, Then Placebo LensesTotal of all reporting groups
Overall Participants997881051
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
9
100%
9
100%
7
100%
8
100%
8
100%
10
100%
51
100%
>=65 years
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
4
44.4%
7
77.8%
4
57.1%
6
75%
7
87.5%
8
80%
36
70.6%
Male
5
55.6%
2
22.2%
3
42.9%
2
25%
1
12.5%
2
20%
15
29.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United States
9
100%
9
100%
7
100%
8
100%
8
100%
10
100%
51
100%
Tactical composite (sum of z scores) [Mean (Standard Deviation) ]
Placebo Lenses
-8.93
(6.42)
-4.94
(3.00)
5.32
(1.77)
3.32
(3.49)
-0.58
(5.77)
2.80
(2.82)
-0.69
(6.44)
Spherical Lenses
0.99
(6.27)
2.26
(5.66)
-2.59
(3.24)
-4.67
(4.73)
3.53
(3.39)
2.78
(1.81)
0.37
(5.22)
Toric Lenses
1.92
(5.00)
1.88
(3.51)
5.32
(3.16)
3.71
(2.66)
-5.18
(4.55)
-7.03
(6.06)
0.32
(6.00)
Operational composite (sum of z scores) [Mean (Standard Deviation) ]
Placebo lenses
-3.95
(3.95)
-4.91
(4.15)
-2.85
(3.23)
-0.78
(4.51)
-7.43
(4.36)
-4.40
(6.28)
-4.06
(4.64)
Spherical lenses
1.28
(1.32)
1.76
(1.27)
1.61
(0.60)
3.15
(1.12)
2.70
(0.74)
1.52
(1.39)
2.01
(1.25)
Toric lenses
2.29
(1.16)
1.70
(1.08)
3.01
(2.01)
2.45
(1.53)
1.30
(0.44)
1.56
(1.99)
2.05
(1.48)

Outcome Measures

1. Primary Outcome
TitleTactical Composite Score
DescriptionThis 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 Frame1 day

Outcome Measure Data

Analysis Population Description
All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
Arm/Group TitleAll Study Participants
Arm/Group DescriptionEach participant completed (1) Simulated driving with Placebo Lenses (AcuVue Oasys Bandage Lenses with no prescription), (2) Simulated driving with Spherical Lenses (1-DAY ACUVUE® MOIST contact lenses), (3) Simulated driving with Toric Lenses (1-DAY ACUVUE® MOIST for ASTIGMATISM contact...
Measure Participants42
Placebo
0.34
(2.44)
Sphere
-0.01
(2.65)
Toric
-0.33
(2.77)
2. Secondary Outcome
TitleOperational Composite Score
DescriptionThis 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 Frame1 day

Outcome Measure Data

Analysis Population Description
All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
Arm/Group TitleAll Study Participants
Arm/Group DescriptionEach participant completed (1) Simulated driving with Placebo Lenses (AcuVue Oasys Bandage Lenses with no prescription), (2) Simulated driving with Spherical Lenses (1-DAY ACUVUE® MOIST contact lenses), (3) Simulated driving with Toric Lenses (1-DAY ACUVUE® MOIST for ASTIGMATISM contact...
Measure Participants42
Placebo
-4.06
(4.64)
Sphere
2.01
(1.25)
Toric
2.05
(1.48)

Adverse Events

Time Frame10 months
Adverse Event Reporting Description
Arm/Group TitlePlaceboSphericalToric
Arm/Group DescriptionParticipants wore the placebo contact lenses during testingParticipants wore the spherical contact lenses during testingParticipants wore the toric contact lenses during testing
All Cause Mortality
PlaceboSphericalToric
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/51 (0%) 0/51 (0%) 0/51 (0%)
Serious Adverse Events
PlaceboSphericalToric
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/51 (0%) 0/51 (0%) 0/51 (0%)
Other (Not Including Serious) Adverse Events
PlaceboSphericalToric
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/51 (3.9%) 2/51 (3.9%) 3/51 (5.9%)
General disorders
Simulation sickness2/51 (3.9%) 2/51 (3.9%) 3/51 (5.9%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitlePrincipal Investigator
OrganizationUniversity of Virginia
Phone434-924-8021
Emaildjc4f@virginia.edu
Responsible Party:
Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier:
NCT02950545
Other Study ID Numbers:
  • 18499
First Posted:
Nov 1, 2016
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021