MyopiaSALUKINCT04205162

Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

A study testing Verafilcon A and Etafilcon A 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 initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist). 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?: Verafilcon A and Etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteCanada
Study dates: 13 Dec 2019to 2 Jun 2022
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 inclusively 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 neophyte who has no history of any previous contact lens handling experience;
Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);
Has visual acuity ≤0.20 logMAR each eye with study lenses;

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Demonstrates acceptable fit with study lenses;
Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye);
Is willing to wear study CLs at least 5 days per week and 6 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 (by self-report);

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Is aphakic;
Has undergone refractive error surgery;
Has taken part in another clinical research study within the last 14 days;
Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
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: Verafilcon A, Etafilcon A
Medical subject headings: Myopia

What participants receive

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

Verafilcon ADevice
Also called Precision1™
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon ADevice
Also called Acuvue® Moist
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Study groups in NCT04205162
Study group	Role	What they receive
Verofilcon A / Etafilcon A	Experimental	The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye. Receives: Device: Verafilcon A; Device: Etafilcon A
Etafilcon A / Verofilcon A	Experimental	The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye. Receives: Device: Verafilcon A; Device: Etafilcon A

What is being measured

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

Subjective Ratings of Lens Handling for Insertion Per Intervention
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
Measured: Baseline
Subjective Ratings of Lens Handling for Removal Per Intervention
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.
Measured: Baseline

Timeline

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

13 Dec 20192 Jun 2022

First posted19 Dec 2019
Study start13 Dec 2019
Primary completion2 Jun 2022
Study completion2 Jun 2022

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04205162
Sponsor's protocol ID: 41693
Acronym: SALUKI
Status last verified: Jan 2023
First submitted: 13 Dec 2019
Last updated: 6 Feb 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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses
ClinicalTrials.gov ID: NCT04205162
Acronym / sponsor ID: SALUKI / 41693
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Alcon Research
Study start: 13 Dec 2019 (actual)
Primary completion: 2 Jun 2022 (actual)
Study completion: 2 Jun 2022 (actual)
First posted: 19 Dec 2019 (actual)
Results: Posted 6 Feb 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Verofilcon A / Etafilcon A	Experimental	Device: Verafilcon A, Device: Etafilcon AThe participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Etafilcon A / Verofilcon A	Experimental	Device: Verafilcon A, Device: Etafilcon AThe participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.

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 inclusively 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 neophyte who has no history of any previous contact lens handling experience;
Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);

Key exclusion criteria (11 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
Verafilcon AAlso: Precision1™Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)	Device	Etafilcon A / Verofilcon A, Verofilcon A / Etafilcon A
Etafilcon AAlso: Acuvue® MoistDaily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)	Device	Etafilcon A / Verofilcon A, Verofilcon A / Etafilcon A

Primary outcome

Subjective Ratings of Lens Handling for Insertion Per Intervention
Time frame: Baseline
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
Subjective Ratings of Lens Handling for Removal Per Intervention
Time frame: Baseline
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.

Results and safety

Results posted to the registry on 6 Feb 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
Verofilcon A / Etafilcon A	18	14
Etafilcon A / Verofilcon A	18	18

Primary outcome: Subjective Ratings of Lens Handling for Insertion Per Intervention

Time frame: Baseline. Median (Full Range). Unit: score on a scale

Measure	Verofilcon A / Etafilcon A n = 18	Etafilcon A / Verofilcon A n = 18
verofilcon A	85 (50 to 99)	80 (17 to 95)
etafilcon A	75 (10 to 100)	85 (50 to 99)

Verofilcon A / Etafilcon A vs Etafilcon A / Verofilcon A: p = 0.331, Wilcoxon (Mann-Whitney)
Verofilcon A / Etafilcon A vs Etafilcon A / Verofilcon A: p = 0.122, Wilcoxon (Mann-Whitney)

Primary outcome: Subjective Ratings of Lens Handling for Removal Per Intervention

Time frame: Baseline. Median (Full Range). Unit: score on a scale

Measure	Verofilcon A / Etafilcon A n = 18	Etafilcon A / Verofilcon A n = 18
etaflicon A	80 (30 to 100)	90 (25 to 99)
verofilcon A	70 (20 to 95)	72.50 (25 to 95)

Verofilcon A / Etafilcon A vs Etafilcon A / Verofilcon A: p = 0.130, Wilcoxon (Mann-Whitney)
Verofilcon A / Etafilcon A vs Etafilcon A / Verofilcon A: p = 0.924, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Average of 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocular Adverse Events Only: Verofilcon A (Per Intervention)	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Ocular Adverse Events Only: Etafilcon A (Per Intervention)	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36
Systemic Adverse Events: Verofilcon A and Etafilcon A	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36

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 6 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

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
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
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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 Verafilcon A and Etafilcon A 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 11 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 Feb 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 6 Feb 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 Ratings of Lens Handling for Insertion Per Intervention (time frame: Baseline). The study lists 2 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 NCT04205162.

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 Feb 2023.