Astigmatism
Conditions
Keywords
astigmatism, contact lens, driving
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.
Interventions
DEVICEPlacebo Lenses
AcuVue Oasys Bandage Lenses with no prescription
DEVICESpherical Lenses
1-DAY ACUVUE® MOIST contact lenses
DEVICEToric Lenses
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Sponsors
Johnson & Johnson Vision Care, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crossover Order 1 Placebo, Spherical, Then Toric Lenses | 9 |
| Crossover Order 2 Placebo, Toric, Then Spherical Lenses | 9 |
| Crossover Order 3 Spherical, Placebo, Then Toric Lenses | 7 |
| Crossover Order 4 Spherical, Toric, Then Placebo Lenses | 8 |
| Crossover Order 5 Toric, Placebo, Then Spherical Lenses | 8 |
| Crossover Order 6 Toric, Spherical, Then Placebo Lenses | 10 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Session 1 (70 Minutes) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 |
| Session 2 (70 Minutes) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
| Session 3 (70 Minutes) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 |
| Washout 1 (5 Minutes) | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 1 |
| Washout 2 (5 Minutes) | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Crossover Order 1 | Crossover Order 2 | Crossover Order 3 | Crossover Order 4 | Crossover Order 5 | Crossover Order 6 |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 9 Participants | 9 Participants | 7 Participants | 8 Participants | 8 Participants | 10 Participants |
| Operational composite Placebo lenses | -4.06 sum of z scores STANDARD_DEVIATION 4.64 | -3.95 sum of z scores STANDARD_DEVIATION 3.95 | -4.91 sum of z scores STANDARD_DEVIATION 4.15 | -2.85 sum of z scores STANDARD_DEVIATION 3.23 | -0.78 sum of z scores STANDARD_DEVIATION 4.51 | -7.43 sum of z scores STANDARD_DEVIATION 4.36 | -4.40 sum of z scores STANDARD_DEVIATION 6.28 |
| Operational composite Spherical lenses | 2.01 sum of z scores STANDARD_DEVIATION 1.25 | 1.28 sum of z scores STANDARD_DEVIATION 1.32 | 1.76 sum of z scores STANDARD_DEVIATION 1.27 | 1.61 sum of z scores STANDARD_DEVIATION 0.6 | 3.15 sum of z scores STANDARD_DEVIATION 1.12 | 2.70 sum of z scores STANDARD_DEVIATION 0.74 | 1.52 sum of z scores STANDARD_DEVIATION 1.39 |
| Operational composite Toric lenses | 2.05 sum of z scores STANDARD_DEVIATION 1.48 | 2.29 sum of z scores STANDARD_DEVIATION 1.16 | 1.70 sum of z scores STANDARD_DEVIATION 1.08 | 3.01 sum of z scores STANDARD_DEVIATION 2.01 | 2.45 sum of z scores STANDARD_DEVIATION 1.53 | 1.30 sum of z scores STANDARD_DEVIATION 0.44 | 1.56 sum of z scores STANDARD_DEVIATION 1.99 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — | — | — |
| Region of Enrollment United States | 51 participants | 9 participants | 9 participants | 7 participants | 8 participants | 8 participants | 10 participants |
| Sex: Female, Male Female | 36 Participants | 4 Participants | 7 Participants | 4 Participants | 6 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 15 Participants | 5 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants |
| Tactical composite Placebo Lenses | -0.69 sum of z scores STANDARD_DEVIATION 6.44 | -8.93 sum of z scores STANDARD_DEVIATION 6.42 | -4.94 sum of z scores STANDARD_DEVIATION 3 | 5.32 sum of z scores STANDARD_DEVIATION 1.77 | 3.32 sum of z scores STANDARD_DEVIATION 3.49 | -0.58 sum of z scores STANDARD_DEVIATION 5.77 | 2.80 sum of z scores STANDARD_DEVIATION 2.82 |
| Tactical composite Spherical Lenses | 0.37 sum of z scores STANDARD_DEVIATION 5.22 | 0.99 sum of z scores STANDARD_DEVIATION 6.27 | 2.26 sum of z scores STANDARD_DEVIATION 5.66 | -2.59 sum of z scores STANDARD_DEVIATION 3.24 | -4.67 sum of z scores STANDARD_DEVIATION 4.73 | 3.53 sum of z scores STANDARD_DEVIATION 3.39 | 2.78 sum of z scores STANDARD_DEVIATION 1.81 |
| Tactical composite Toric Lenses | 0.32 sum of z scores STANDARD_DEVIATION 6 | 1.92 sum of z scores STANDARD_DEVIATION 5 | 1.88 sum of z scores STANDARD_DEVIATION 3.51 | 5.32 sum of z scores STANDARD_DEVIATION 3.16 | 3.71 sum of z scores STANDARD_DEVIATION 2.66 | -5.18 sum of z scores STANDARD_DEVIATION 4.55 | -7.03 sum of z scores STANDARD_DEVIATION 6.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 2 / 51 | 2 / 51 | 3 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 | 0 / 51 |
Outcome results
Primary
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.
Time frame: 1 day
Population: All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Tactical Composite Score | Placebo | 0.34 score on a scale | Standard Deviation 2.44 |
| All Study Participants | Tactical Composite Score | Sphere | -0.01 score on a scale | Standard Deviation 2.65 |
| All Study Participants | Tactical Composite Score | Toric | -0.33 score on a scale | Standard Deviation 2.77 |
Secondary
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.
Time frame: 1 day
Population: All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Operational Composite Score | Placebo | -4.06 score on a scale | Standard Deviation 4.64 |
| All Study Participants | Operational Composite Score | Sphere | 2.01 score on a scale | Standard Deviation 1.25 |
| All Study Participants | Operational Composite Score | Toric | 2.05 score on a scale | Standard Deviation 1.48 |