MyopiaPUGNCT04201639

Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

A study testing Verofilcon A contact lenses in people with Myopia, run by University of Waterloo at 1 site in Canada.

Completed

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

Trial summary

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day). Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Verofilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: 13 Dec 2019to 27 Sep 2021
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;

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Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

Who cannot join

Is participating in any concurrent clinical or research study;
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 the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment;

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Is aphakic;
Has undergone refractive error surgery;
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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Myopia
Being tested: Verofilcon A contact lenses
Medical subject headings: Myopia

What participants receive

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

Verofilcon A contact lensesDevice
Also called Precision1™
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Study groups in NCT04201639
Study group	Role	What they receive
Refit	Experimental	Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. Receives: Device: Verofilcon A contact lenses

What is being measured

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

Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Dispense Visit (Day 0)
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Measured: Dispense Visit (Day 0)
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Measured: Dispense Visit (Day 0)
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Measured: Day 1
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
Measured: Day 7
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Measured: Day 10
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
Measured: Followup visit (occurring at a single visit any day from Day 12-16)

Timeline

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

13 Dec 201927 Sep 2021

First posted17 Dec 2019
Study start13 Dec 2019
Primary completion27 Sep 2021
Study completion27 Sep 2021

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 MyopiaStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04201639
Sponsor's protocol ID: 41694
Acronym: PUG
Status last verified: Jan 2023
First submitted: 13 Dec 2019
Last updated: 26 Jan 2023
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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
ClinicalTrials.gov ID: NCT04201639
Acronym / sponsor ID: PUG / 41694
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Alcon Research
Study start: 13 Dec 2019 (actual)
Primary completion: 27 Sep 2021 (actual)
Study completion: 27 Sep 2021 (actual)
First posted: 17 Dec 2019 (actual)
Results: Posted 26 Jan 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Refit	Experimental	Device: Verofilcon A contact lensesRefit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;

Key exclusion criteria (9 listed)

Is participating in any concurrent clinical or research study;
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 the diagnostic pharmaceuticals 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
Verofilcon A contact lensesAlso: Precision1™Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)	Device	Refit

Primary outcome

Subjective Comfort After Contact Lens Insertion
Time frame: Dispense Visit (Day 0)
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Dryness After Contact Lens Insertion
Time frame: Dispense Visit (Day 0)
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time frame: Dispense Visit (Day 0)
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Subjective Comfort After Contact Lens Insertion
Time frame: Day 1
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Dryness After Contact Lens Insertion
Time frame: Day 1
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time frame: Day 1
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Subjective Comfort After Contact Lens Insertion
Time frame: Day 7
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Dryness After Contact Lens Insertion
Time frame: Day 7
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time frame: Day 7
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Subjective Comfort After Contact Lens Insertion
Time frame: Day 10
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Dryness After Contact Lens Insertion
Time frame: Day 10
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time frame: Day 10
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Subjective Comfort After Contact Lens Insertion
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Dryness After Contact Lens Insertion
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 1
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 1
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 1
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 7
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 7
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 7
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 10
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 10
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Day 10
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 1
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Dryness at End of Day With Contact Lens Wear
Time frame: Day 1
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time frame: Day 1
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 7
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Dryness at End of Day With Contact Lens Wear
Time frame: Day 7
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time frame: Day 7
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 10
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Dryness at End of Day With Contact Lens Wear
Time frame: Day 10
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time frame: Day 10
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Dryness at End of Day With Contact Lens Wear
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Refit	32	32

Primary outcome: Subjective Comfort After Contact Lens Insertion

Time frame: Dispense Visit (Day 0). Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	95 (40 to 100)

Primary outcome: Subjective Dryness After Contact Lens Insertion

Time frame: Dispense Visit (Day 0). Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	100 (70 to 100)

Primary outcome: Subjective Rating of Clarity of Vision After Contact Lens Insertion

Time frame: Dispense Visit (Day 0). Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	98 (70 to 100)

Primary outcome: Subjective Comfort After Contact Lens Insertion

Time frame: Day 1. Mean (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	96 (75 to 100)

Adverse events

Time frame: 12-16 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Refit	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32

Limitations and caveats (from the sponsor): The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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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.

Lyndon Jones, PhD, FCOptom principal investigator

Centre for Ocular Research & Education

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

Questions about this trial

What is this clinical trial studying?

A study testing Verofilcon A contact lenses in people with Myopia, run by University of Waterloo 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 9 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 26 Jan 2023. 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 Jan 2023). 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?

Subjective Comfort After Contact Lens Insertion (time frame: Dispense Visit (Day 0)). The study lists 39 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 NCT04201639.

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 26 Jan 2023.