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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Placebo Lenses
* Device: Spherical Lenses
* Device: Toric Lenses


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo, Spherical, then Toric Lenses<br>Crossover order 1 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|
| Experimental: Placebo, Toric, then Spherical Lenses<br>Crossover order 2 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|
| Experimental: Spherical, Placebo, then Toric Lenses<br>Crossover order 3 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|
| Experimental: Spherical, Toric, then Placebo Lenses<br>Crossover order 4 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|
| Experimental: Toric, Placebo, then Spherical Lenses<br>Crossover order 5 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|
| Experimental: Toric, Spherical, then Placebo Lenses<br>Crossover order 6 | Device: Placebo Lenses<br>* AcuVue Oasys Bandage Lenses with no prescription<br>Device: Spherical Lenses<br>* 1-DAY ACUVUE® MOIST contact lenses<br>Device: Toric Lenses<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astigmatism, contact lens, driving