Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
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 |
---|---|---|
|
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
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
- 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
- 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
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)
More Information
Publications
- 18499
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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
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)
|
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 | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
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
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/Title | Principal Investigator |
---|---|
Organization | University of Virginia |
Phone | 434-924-8021 |
djc4f@virginia.edu |
- 18499