AstigmatismNCT02950545
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
A study testing Spherical Lenses and Toric Lenses in people with Astigmatism, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Spherical Lenses and Toric Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Driving Safety Laboratory
Charlottesville, Virginia, 22908
About this study
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.
Read the 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
- Being tested
- Placebo Lenses, Spherical Lenses, Toric Lenses
- Keywords
- astigmatism, contact lens, driving
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo LensesDevice
AcuVue Oasys Bandage Lenses with no prescription
Spherical LensesDevice
1-DAY ACUVUE® MOIST contact lenses
Toric LensesDevice
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Spherical, then Toric Lenses | Experimental | Crossover order 1 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
| Placebo, Toric, then Spherical Lenses | Experimental | Crossover order 2 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
| Spherical, Placebo, then Toric Lenses | Experimental | Crossover order 3 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
| Spherical, Toric, then Placebo Lenses | Experimental | Crossover order 4 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
| Toric, Placebo, then Spherical Lenses | Experimental | Crossover order 5 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
| Toric, Spherical, then Placebo Lenses | Experimental | Crossover order 6 Receives: Device: Placebo Lenses; Device: Spherical Lenses; Device: Toric Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startApr 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Responsible party
- Principal investigator, Daniel Cox, PhD, University of Virginia
- Investigators
- Daniel J Cox, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950545
- Sponsor's protocol ID
- 18499
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2016
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data and protocol will be shared on request.
Publications
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.
PubMed 25946099
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
- ClinicalTrials.gov ID
- NCT02950545
- Acronym / sponsor ID
- 18499
- Conditions
- Astigmatism
- Keywords
- astigmatism, contact lens, driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- Apr 2016
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo, Spherical, then Toric Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 1 |
| Placebo, Toric, then Spherical Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 2 |
| Spherical, Placebo, then Toric Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 3 |
| Spherical, Toric, then Placebo Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 4 |
| Toric, Placebo, then Spherical Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 5 |
| Toric, Spherical, then Placebo Lenses | Experimental | Device: Placebo Lenses, Device: Spherical Lenses, Device: Toric LensesCrossover order 6 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- Corrected vision worse than 20/40 in either eye
- No astigmatism in either eye
- Active eye infection
- Defective peripheral vision
- Wears bifocals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo LensesAcuVue Oasys Bandage Lenses with no prescription | Device | 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 |
| Spherical Lenses1-DAY ACUVUE® MOIST contact lenses | Device | 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 |
| Toric Lenses1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses | Device | 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 |
Primary outcome
Tactical Composite Score
Time frame: 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.
1 secondary outcome
Operational Composite Score
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25946099Cox 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.
- Individual participant dataSharing planned: Yes. Data and protocol will be shared on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Cox, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spherical Lenses and Toric Lenses in people with Astigmatism, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactical Composite Score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.