Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johnson & Johnson Vision Care, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Spherical, then Toric Lenses | Experimental | Crossover order 1 |
|
| Placebo, Toric, then Spherical Lenses | Experimental | Crossover order 2 |
|
| Spherical, Placebo, then Toric Lenses | Experimental | Crossover order 3 |
|
| Spherical, Toric, then Placebo Lenses | Experimental | Crossover order 4 |
|
| Toric, Placebo, then Spherical Lenses | Experimental | Crossover order 5 |
|
| Toric, Spherical, then Placebo Lenses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Lenses | Device | AcuVue Oasys Bandage Lenses with no prescription |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel J Cox, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Driving Safety Laboratory | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25946099 | Background | 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. |
Not provided
Not provided
Data and protocol will be shared on request.
Data will be available on request
data will be shared via e-mail.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Order 1 | Placebo, Spherical, then Toric lenses |
| FG001 | Crossover Order 2 | Placebo, Toric, then Spherical lenses |
| FG002 | Crossover Order 3 | Spherical, Placebo, then Toric lenses |
| FG003 | Crossover Order 4 | Spherical, Toric, then Placebo lenses |
| FG004 | Crossover Order 5 | Toric, Placebo, then Spherical lenses |
| FG005 | Crossover Order 6 | Toric, Spherical, then Placebo lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1 (70 Minutes) |
|
| ||||||||||||||||||
| Washout 1 (5 Minutes) |
| |||||||||||||||||||
| Session 2 (70 Minutes) |
| |||||||||||||||||||
| Washout 2 (5 Minutes) |
| |||||||||||||||||||
| Session 3 (70 Minutes) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Order 1 | Placebo, Spherical, Then Toric Lenses |
| BG001 | Crossover Order 2 | Placebo, Toric, Then Spherical Lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants were 18 to 39 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
10 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants wore the placebo contact lenses during testing | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Simulation sickness | General disorders | Non-systematic Assessment | motion sickness induced by simulator use. |
The study primarily investigated vehicle control. Object recognition is also a critical aspect of driving, but was not fully investigated in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Virginia | 434-924-8021 | djc4f@virginia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2015 | Apr 23, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Crossover order 6 |
|
| Spherical Lenses | Device | 1-DAY ACUVUE® MOIST contact lenses |
|
| Toric Lenses | Device | 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Crossover Order 3 | Spherical, Placebo, Then Toric Lenses |
| BG003 | Crossover Order 4 | Spherical, Toric, Then Placebo Lenses |
| BG004 | Crossover Order 5 | Toric, Placebo, Then Spherical Lenses |
| BG005 | Crossover Order 6 | Toric, Spherical, Then Placebo Lenses |
| BG006 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tactical composite | 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. | Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1). | Mean | Standard Deviation | sum of z scores |
|
| Operational composite | 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. | Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1). | Mean | Standard Deviation | sum of z scores |
|
|
|
| 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. | All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| 51 |
| 0 |
| 51 |
| 2 |
| 51 |
| EG001 | Spherical | Participants wore the spherical contact lenses during testing | 0 | 51 | 0 | 51 | 2 | 51 |
| EG002 | Toric | Participants wore the toric contact lenses during testing | 0 | 51 | 0 | 51 | 3 | 51 |
|
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
|
|
| Title | Measurements |
|---|---|
|