MyopiaNCT04305912
Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
A study testing somofilcon A and verofilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- somofilcon A and verofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2020to 30 Aug 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
- A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age 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;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
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- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Has an astigmatism of ≤ 1.00 D in subjective refraction;
- Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Who cannot join
- -
- A person may be excluded from the study if he/she:
- 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;
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- 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 because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research \& Education;
- Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
- Has participated in any clinical trials within a week prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.
Read the detailed description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).
- Conditions
- Myopia
- Being tested
- somofilcon A, verofilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somofilcon ADevice
Also called Clariti 1 Day
Subjects will be randomized to wear somofilcon A daily disposable lenses.
verofilcon ADevice
Also called Precision 1
Subjects will be randomized to wear verofilcon A daily disposable lenses.
| Study group | Role | What they receive |
|---|---|---|
| somofilcon A | Experimental | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week. Receives: Device: somofilcon A |
| verofilcon A | Active comparator | Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. Receives: Device: verofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Ratings for Lens Handling for Lens Insertion
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Measured: 1 week
Subjective Ratings for Lens Handling for Lens Removal
Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).
Measured: 1 week
Secondary outcomes (6)
Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive \& occasionally encroaching limbus)
Measured: Baseline
Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive \& occasionally encroaching limbus)
Measured: 1-week
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Measured: Baseline
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Measured: 1-week
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Measured: Baseline
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start19 Feb 2020
- Primary completion28 Aug 2021
- Study completion30 Aug 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD FCOptom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305912
- Sponsor's protocol ID
- EX-MKTG-113
- Status last verified
- Feb 2022
- First submitted
- 9 Mar 2020
- Last updated
- 14 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Walsh K, Moezzi AM, Guthrie S, Woods J, Vega J. Clinical Performance and Wearer Experience with Two Contemporary Daily Disposable Silicone Hydrogel Lenses. Clin Optom (Auckl). 2026 Sep 26;18:628296. doi: 10.2147/OPTO.S628296. eCollection 2026.
PubMed 42866799
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
- ClinicalTrials.gov ID
- NCT04305912
- Acronym / sponsor ID
- EX-MKTG-113
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.
Detailed description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somofilcon A | Experimental | Device: somofilcon ASubjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week. |
| verofilcon A | Active comparator | Device: verofilcon ASubjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- -
- Is at least 17 years of age 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;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
Key exclusion criteria (13 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;
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 |
|---|---|---|
| somofilcon AAlso: Clariti 1 DaySubjects will be randomized to wear somofilcon A daily disposable lenses. | Device | somofilcon A |
| verofilcon AAlso: Precision 1Subjects will be randomized to wear verofilcon A daily disposable lenses. | Device | verofilcon A |
Primary outcome
Subjective Ratings for Lens Handling for Lens Insertion
Time frame: 1 week
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Subjective Ratings for Lens Handling for Lens Removal
Time frame: 1 week
Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).
6 secondary outcomes
Lens Fit - Centration
Time frame: Baseline
Lens Fit - Centration
Time frame: 1-week
Lens Fit - Post-blink Movement
Time frame: Baseline
Lens Fit - Post-blink Movement
Time frame: 1-week
Lens Fit - Lens Push-up Tightness
Time frame: Baseline
Lens Fit - Lens Push-up Tightness
Time frame: 1-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42866799Walsh K, Moezzi AM, Guthrie S, Woods J, Vega J. Clinical Performance and Wearer Experience with Two Contemporary Daily Disposable Silicone Hydrogel Lenses. Clin Optom (Auckl). 2026 Sep 26;18:628296. doi: 10.2147/OPTO.S628296. eCollection 2026.
- Individual participant dataSharing planned: No
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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
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somofilcon A and verofilcon A in people with Myopia, 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 11 inclusion and 13 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 14 Feb 2022. 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 11 Feb 2022). 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 for Lens Handling for Lens Insertion (time frame: 1 week). 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 NCT04305912, 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 14 Feb 2022.