AstigmatismNCT02624791

Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

A study testing 1-DAY ACUVUE® MOIST contact lenses, 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses and No contact lenses in people with Astigmatism, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: 1-DAY ACUVUE® MOIST contact lenses, 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses and No contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jan 2013
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 drivers between the ages of 18-39, similar number of males and females will be studied who meet the following inclusion criteria:
Bilateral corrected vision of 20/40 or better
Bilateral astigmatism between 0.75 to 2.0 diopters, with spherical correction from -1 to -6
No active eye infection
No defective peripheral vision
Do not have correction for bifocals

Show all 9Show fewer

Routinely wear contact lenses more than 4 times per week
Routinely drive a car more than 4 times week
Do not have a history of motion, sea or big screen (e.g. IMAX) sickness or experience persistent Simulation Adaptation Syndrome

Who cannot join

Bilateral corrected vision of worse than 20/40
No astigmatism
Active eye infection
Defective peripheral vision
Wear 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 Lab
Charlottesville, Virginia, 22908

Other trials in United States

About this study

Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with respect to driving is unknown, but it could threaten safe operation of a motor vehicle, especially under conditions such as nighttime driving when visual abilities are highly challenged. This study measures driving-specific visual abilities and simulated driving performance in participants with astigmatism who either have or do not have their astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for astigmatism will result in safer driving performance overall. The secondary hypothesis is that at an operational level, contact lenses correcting for astigmatism will result in better driving-specific visual performance.

Read the detailed description

Safe driving relies heavily on "good vision." Good vision while driving relates to multiple abilities, such as dynamic visual acuity, contrast sensitivity, management of glare and peripheral vision, etc. While spherical contact lenses address issues of correction of visual acuity as determined by forward static vision tests, if they do not provide visual acuity both immediately and smoothly with eye movement then vision can be compromised. Glare can be a problem as well when contact lenses are off center. Fluctuating vision as a result of lens movement on the eye could be especially problematic and frustrating for patients who have astigmatism. Furthermore, experiencing moments of blurred vision no matter how brief can be potentially hazardous while driving. The 1*DAY ACUVUE® MOIST for ASTIGMATISM contact lenses have a unique blink-activated stabilization system to prevent rotation of the lens on the eye, and may have significant visual advantages for drivers with astigmatism. These lenses provide continuous corrected acuity compared to non-ballasted contact lenses, and thus are potentially safer for driving. Contact comparison will consist of 1*DAY ACUVUE® MOIST (spherical control) versus 1*DAY ACUVUE® MOIST for ASTIGMATISM (the daily disposable astigmatism alternative).

The study will investigate the potential advantages of contact lenses specifically designed to correct for astigmatism, compared to similar correction with spherical contacts, for adult licensed drivers with astigmatism, employing a double-blind (subjects and research assistant blind to hypotheses), randomized, cross-over design (spherical, vs. astigmatism contacts). This will be a multi-stage study comprised of the following:

Preliminary study to determine the likelihood of detecting a significant difference between the standard spherical and astigmatism contacts in a full Randomize Clinical Trial (n=12; data and power analysis)

Conditions: Astigmatism
Being tested: 1-DAY ACUVUE® MOIST contact lenses, 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, No contact 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.

1-DAY ACUVUE® MOIST contact lensesDevice
spherical contact lenses worn during simulated driving tests
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lensesDevice
toric contact lenses worn during simulated driving tests
No contact lensesOther
simulated driving tests

Study groups in NCT02624791
Study group	Role	What they receive
Lens sequence 1	Experimental	No contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses
Lens sequence 2	Experimental	No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses
Lens sequence 3	Experimental	1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses
Lens sequence 4	Experimental	1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses
Lens sequence 5	Experimental	1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses
Lens sequence 6	Experimental	1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses Receives: Device: 1-DAY ACUVUE® MOIST contact lenses; Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; Other: No contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Tactical Composite Score
Z-score composite of tactical testing outcomes
Measured: 1 day laboratory study

Secondary outcomes (1)

Operational Composite Score
Z-score composite of operational testing outcomes
Measured: 1 day laboratory study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jan 2013

First posted8 Dec 2015 (estimated)
Study startSep 2012
Primary completionJan 2013
Study completionJan 2013

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: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02624791
Sponsor's protocol ID: 15920
Status last verified: Feb 2020
First submitted: 30 Dec 2013
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. 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
ClinicalTrials.gov ID: NCT02624791
Acronym / sponsor ID: 15920
Conditions: Astigmatism
Keywords: astigmatism, contact lens, driving
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Johnson & Johnson Vision Care, Inc.
Study start: Sep 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 8 Dec 2015 (estimated)
Results: Posted 23 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Lens sequence 1	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lensesNo contact lenses; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Lens sequence 2	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lensesNo contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses
Lens sequence 3	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lenses1-DAY ACUVUE® MOIST contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Lens sequence 4	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lenses1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses
Lens sequence 5	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lenses1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; 1-DAY ACUVUE® MOIST contact lenses; No contact lenses
Lens sequence 6	Experimental	Device: 1-DAY ACUVUE® MOIST contact lenses, Device: 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses, Other: No contact lenses1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses; 1-DAY ACUVUE® MOIST contact lenses

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Adult licensed drivers between the ages of 18-39, similar number of males and females will be studied who meet the following inclusion criteria:
Bilateral corrected vision of 20/40 or better
Bilateral astigmatism between 0.75 to 2.0 diopters, with spherical correction from -1 to -6
No active eye infection
No defective peripheral vision

Key exclusion criteria (7 listed)

Bilateral corrected vision of worse than 20/40
No astigmatism
Active eye infection
Defective peripheral vision
Wear 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
1-DAY ACUVUE® MOIST contact lensesspherical contact lenses worn during simulated driving tests	Device	Lens sequence 1, Lens sequence 2, Lens sequence 3, Lens sequence 4, Lens sequence 5, Lens sequence 6
1-DAY ACUVUE® MOIST for ASTIGMATISM contact lensestoric contact lenses worn during simulated driving tests	Device	Lens sequence 1, Lens sequence 2, Lens sequence 3, Lens sequence 4, Lens sequence 5, Lens sequence 6
No contact lensessimulated driving tests	Other	Lens sequence 1, Lens sequence 2, Lens sequence 3, Lens sequence 4, Lens sequence 5, Lens sequence 6

Primary outcome

Tactical Composite Score
Time frame: 1 day laboratory study
Z-score composite of tactical testing outcomes

1 secondary outcome

Operational Composite Score
Time frame: 1 day laboratory study

Results and safety

Results posted to the registry on 23 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lens Sequence 1	2	0
Lens Sequence 2	1	1
Lens Sequence 3	2	2
Lens Sequence 4	2	2
Lens Sequence 5	2	2
Lens Sequence 6	2	2

Primary outcome: Tactical Composite Score

Time frame: 1 day laboratory study. Mean (Standard Deviation). Unit: Z score

Measure	Contact Lens Rx n = 9
None	-1.73 (3.53)
Sphere	0.19 (2.62)
Toric	1.54 (1.75)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Contact Lens Rx	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): small number of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: 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: Undecided

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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, Ph.D. 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?

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 9 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 Mar 2020. 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 23 May 2017). 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 laboratory study). 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 NCT02624791, 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 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.