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)
• Enrollment: 51
• Location: 1
• Arms: 6
• Duration (Months): 10.1
• Patients Per Site Per Month: 5.1

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 Disease	Intervention/Treatment	Phase
Astigmatism	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

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

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

	Site	City	State	Country	Postal Code
1	University of Virginia Driving Safety Laboratory	Charlottesville	Virginia	United States	22908

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)

• Study Protocol and Statistical Analysis Plan - Dec 10, 2015

More Information

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.

• 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: astigmatism, contact lens, driving
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Crossover Order 1	Crossover Order 2	Crossover Order 3	Crossover Order 4	Crossover Order 5	Crossover Order 6
Arm/Group Description	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
Period Title: Session 1 (70 Minutes)
STARTED	9	9	7	8	8	10
COMPLETED	9	9	7	8	8	9
NOT COMPLETED	0	0	0	0	0	1
Period Title: Session 1 (70 Minutes)
STARTED	9	9	7	8	8	9
COMPLETED	8	9	7	7	8	8
NOT COMPLETED	1	0	0	1	0	1
Period Title: Session 1 (70 Minutes)
STARTED	8	9	7	7	8	8
COMPLETED	8	9	7	7	7	8
NOT COMPLETED	0	0	0	0	1	0
Period Title: Session 1 (70 Minutes)
STARTED	8	9	7	7	7	8
COMPLETED	7	9	7	7	7	8
NOT COMPLETED	1	0	0	0	0	0
Period Title: Session 1 (70 Minutes)
STARTED	7	9	7	7	7	8
COMPLETED	7	9	7	7	7	7
NOT COMPLETED	0	0	0	0	0	1

Baseline Characteristics

Arm/Group Title	Crossover Order 1	Crossover Order 2	Crossover Order 3	Crossover Order 4	Crossover Order 5	Crossover Order 6	Total
Arm/Group Description	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	Total of all reporting groups
Overall Participants	9	9	7	8	8	10	51
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

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

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 Title	All Study Participants
Arm/Group Description	Each 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 Participants	42
Placebo	0.34 (2.44)
Sphere	-0.01 (2.65)
Toric	-0.33 (2.77)

2. Secondary Outcome

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

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 Title	All Study Participants
Arm/Group Description	Each 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 Participants	42
Placebo	-4.06 (4.64)
Sphere	2.01 (1.25)
Toric	2.05 (1.48)

Adverse Events

Time Frame	10 months
Arm/Group Title	Placebo		Spherical		Toric
Arm/Group Description	Participants wore the placebo contact lenses during testing		Participants wore the spherical contact lenses during testing		Participants wore the toric contact lenses during testing
All Cause Mortality
	Placebo		Spherical		Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)		0/51 (0%)
Serious Adverse Events
	Placebo		Spherical		Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Spherical		Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/51 (3.9%)		2/51 (3.9%)		3/51 (5.9%)
General disorders
Simulation sickness	2/51 (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.