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

NCT ID: NCT02950545

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-02-01

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.

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo, Spherical, then Toric Lenses

Crossover order 1

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Placebo, Toric, then Spherical Lenses

Crossover order 2

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Spherical, Placebo, then Toric Lenses

Crossover order 3

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Spherical, Toric, then Placebo Lenses

Crossover order 4

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Toric, Placebo, then Spherical Lenses

Crossover order 5

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Toric, Spherical, then Placebo Lenses

Crossover order 6

Group Type: EXPERIMENTAL

Placebo Lenses

Intervention Type: DEVICE

AcuVue Oasys Bandage Lenses with no prescription

Spherical Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST contact lenses

Toric Lenses

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Interventions

Placebo Lenses

AcuVue Oasys Bandage Lenses with no prescription

Intervention Type: DEVICE

Spherical Lenses

1-DAY ACUVUE® MOIST contact lenses

Intervention Type: DEVICE

Toric Lenses

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cox, PhD

Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Driving Safety Laboratory

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25946099 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18499

Identifier Type: -

Identifier Source: org_study_id