AstigmatismNCT03134248

Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

A study testing Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism and MyDay Toric in people with Astigmatism, run by CooperVision, Inc. at 1 site in Canada.

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

Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Astigmatism
What is being tested?: Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism and MyDay Toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteCanada
Study dates: 19 Oct 2016to 12 Apr 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer;
Is willing to wear contact lens in both eyes for the duration of the study;

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Has a minimum spectacle astigmatism of - 0.75;
Can be fit with the three study contact lens types in the powers available;
Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
Has clear corneas and no active* ocular disease;
For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Who cannot join

Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to fluorescein dye or products to be used in the study;
Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

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Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery.

Trial locations and contacts

1 site in 1 country.

Canada1 site

CCLR, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Read the detailed description

Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses

Conditions: Astigmatism
Being tested: Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism, MyDay Toric
Medical subject headings: Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dailies Aquacomfort Plus ToricDevice
Also called DACP
daily disposable contact lens
1-Day Acuvue Moist for AstigmatismDevice
Also called 1-Day AM
daily disposable contact lens
MyDay ToricDevice
Also called MDT
daily disposable contact lens

Study groups in NCT03134248
Study group	Role	What they receive
MyDay Toric	Experimental	Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study Receives: Device: MyDay Toric
1-Day Acuvue Moist for Astigmatism	Active comparator	Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study Receives: Device: 1-Day Acuvue Moist for Astigmatism
Dailies Aquacomfort Plus Toric	Active comparator	Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study Receives: Device: Dailies Aquacomfort Plus Toric

What is being measured

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

Comfort
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Measured: 1 week
Dryness
Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Measured: 1 week
Visual Quality
Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Measured: 1 week
Lens Preference With Respect to Overall Comfort
Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Measured: 1 week
Lens Preference With Respect to Visual Quality
Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Measured: 1 week

Timeline

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

19 Oct 201612 Apr 2017

First posted28 Apr 2017
Study start19 Oct 2016
Primary completion12 Apr 2017
Study completion12 Apr 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.
Other trials for AstigmatismStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03134248
Sponsor's protocol ID: EX-MKTG-72
Status last verified: Aug 2019
First submitted: 12 Apr 2017
Last updated: 12 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
ClinicalTrials.gov ID: NCT03134248
Acronym / sponsor ID: EX-MKTG-72
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 19 Oct 2016 (actual)
Primary completion: 12 Apr 2017 (actual)
Study completion: 12 Apr 2017 (actual)
First posted: 28 Apr 2017 (actual)
Results: Posted 26 Jun 2018

Clinical summary

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

Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
MyDay Toric	Experimental	Device: MyDay ToricParticipants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study
1-Day Acuvue Moist for Astigmatism	Active comparator	Device: 1-Day Acuvue Moist for AstigmatismParticipants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study
Dailies Aquacomfort Plus Toric	Active comparator	Device: Dailies Aquacomfort Plus ToricParticipants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer;

Key exclusion criteria (9 listed)

Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to fluorescein dye or products to be used in the study;

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
Dailies Aquacomfort Plus ToricAlso: DACPdaily disposable contact lens	Device	Dailies Aquacomfort Plus Toric
1-Day Acuvue Moist for AstigmatismAlso: 1-Day AMdaily disposable contact lens	Device	1-Day Acuvue Moist for Astigmatism
MyDay ToricAlso: MDTdaily disposable contact lens	Device	MyDay Toric

Primary outcome

Comfort
Time frame: 1 week
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Dryness
Time frame: 1 week
Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Visual Quality
Time frame: 1 week
Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Lens Preference With Respect to Overall Comfort
Time frame: 1 week
Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Lens Preference With Respect to Visual Quality
Time frame: 1 week
Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference

Results and safety

Results posted to the registry on 26 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-Day AM First, Then DACP, Then MDT	7	7
1-Day AM First, Then MDT, Then DACP	8	8
DACP First, Then 1-Day AM, Then MDT	9	9
DACP First, Then MDT, Then 1-Day AM	7	7
MDT First, Then 1-Day AM, Then DACP	9	9
MDT First, Then DACP, Then 1-Day AM	9	9

Primary outcome: Comfort

Time frame: 1 week. Median (Standard Deviation). Unit: units on a scale

Measure	MyDay Toric Contact Lens n = 49	1-Day Acuvue Moist for Astigmatism Contact Lens n = 49	Dailies Aquacomfort Plus Toric Contact Lens n = 49
Value	8 (1.37)	9 (1.14)	8 (2.05)

Primary outcome: Dryness

Time frame: 1 week. Median (Standard Deviation). Unit: units on a scale

Measure	MyDay Toric Contact Lens n = 49	1-Day Acuvue Moist for Astigmatism Contact Lens n = 49	Dailies Aquacomfort Plus Toric Contact Lens n = 49
Value	9 (1.69)	8 (1.65)	7 (2.18)

Primary outcome: Visual Quality

Time frame: 1 week. Median (Standard Deviation). Unit: units on a scale

Measure	MyDay Toric Contact Lens n = 49	1-Day Acuvue Moist for Astigmatism Contact Lens n = 49	Dailies Aquacomfort Plus Toric Contact Lens n = 49
Value	9 (1.41)	8 (1.14)	8 (1.81)

Primary outcome: Lens Preference With Respect to Overall Comfort

Time frame: 1 week. Count of participants. Unit: Participants

Measure	Overall Study n = 49
Strongly Prefer MyDay Toric	15
Slightly Prefer MyDay Toric	6
Strongly Prefer 1Day Acuvue Moist Toric	14
Slightly Prefer 1Day Acuvue Moist Toric	5
Strongly Prefer Dailies Aquacomfort Plus Toric	5
Slighlty Prefer Dailies Aquacomfort Plus Toric	3
No Preference	1

Adverse events

Time frame: Adverse events were collected during the 3 week study duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MyDay Toric	0 of 49 (0%)	0 of 49 (0%)	0 of 49
1-Day Acuvue Moist for Astigmatism	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Dailies Aqua Comfort Plus Toric	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Astigmatism

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

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism and MyDay Toric in people with Astigmatism, run by CooperVision, Inc. at 1 site in Canada.

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 12 inclusion and 9 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 12 Sep 2019. 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 Canada. 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 26 Jun 2018). 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?

Comfort (time frame: 1 week). The study lists 5 primary outcomes in all. 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 NCT03134248.

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 12 Sep 2019.