AmetropiaNCT07104773
Clinical Investigation of Proclear® 1 Day and MyDay® Sphere Contact Lenses
A study testing Test Lens (stenfilcon A) in people with Ametropia and Myopia, run by CooperVision International Limited (CVIL) at 1 site in Canada.
Trial summary
The aim of this study is to evaluate and compare the performance of two soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Test Lens (stenfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2025to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age and have capacity to consent;
- Have understood and signed an information consent form;
- Are an adapted soft contact lens wearer (worn for at least 3 months);
- Have a contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
- Have a refraction with a cylinder component of no more than -0.75DC in each eye;
- Can achieve a best spectacle-corrected visual acuity in each eye of +0.10 logMAR or better.
Who cannot join
- Participation in a contact lens or contact lens care product clinical trial in the previous 30 days;
- Have any known active anterior segment disease and/or infection or slit lamp findings that would contraindicate contact lens wear;
- Have a systemic condition that would contraindicate contact lens wear;
- Are using any systemic or topical medications that would contraindicate contact lens wear;
- Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
- Are an employee of the study site (Centre for Ocular Research \& Education) and directly involved in the study (ie. on the delegation log).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
Read the detailed description
The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing soft lens wearers.
- Being tested
- Control Lens (omafilcon A), Test Lens (stenfilcon A)
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Lens (omafilcon A)Device
15 minutes of daily wear
Test Lens (stenfilcon A)Device
15 minutes of daily wear
| Study group | Role | What they receive |
|---|---|---|
| Control Lens (omafilcon A) | Experimental | All participants will wear Control Lens for 15 minutes (Period 1). Receives: Device: Control Lens (omafilcon A) |
| Test Lens (stenfilcon A) | Experimental | All participants will wear Test Lens for 15 minutes (Period 2). Receives: Device: Test Lens (stenfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Comfort Rating
The primary outcome of this study is lens comfort on a scale of 0-100 (0= worst, 100=best).
Measured: At the end of 15 minutes of daily wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Jul 2025
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Responsible party
- Sponsor
- Investigators
- Jill Woods, MSc, MCOptom, Principal investigator, Centre of Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104773
- Sponsor's protocol ID
- EX-MKTG-169
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Proclear® 1 Day and MyDay® Sphere Contact Lenses
- ClinicalTrials.gov ID
- NCT07104773
- Acronym / sponsor ID
- EX-MKTG-169
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
Detailed description
The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing soft lens wearers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Lens (omafilcon A) | Experimental | Device: Control Lens (omafilcon A)All participants will wear Control Lens for 15 minutes (Period 1). |
| Test Lens (stenfilcon A) | Experimental | Device: Test Lens (stenfilcon A)All participants will wear Test Lens for 15 minutes (Period 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 18 years of age and have capacity to consent;
- Have understood and signed an information consent form;
- Are an adapted soft contact lens wearer (worn for at least 3 months);
- Have a contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
- Have a refraction with a cylinder component of no more than -0.75DC in each eye;
Key exclusion criteria (6 listed)
- Participation in a contact lens or contact lens care product clinical trial in the previous 30 days;
- Have any known active anterior segment disease and/or infection or slit lamp findings that would contraindicate contact lens wear;
- Have a systemic condition that would contraindicate contact lens wear;
- Are using any systemic or topical medications that would contraindicate contact lens wear;
- Have known sensitivity to the diagnostic fluorescein sodium 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 |
|---|---|---|
| Control Lens (omafilcon A)15 minutes of daily wear | Device | Control Lens (omafilcon A) |
| Test Lens (stenfilcon A)15 minutes of daily wear | Device | Test Lens (stenfilcon A) |
Primary outcome
Subjective Comfort Rating
Time frame: At the end of 15 minutes of daily wear
The primary outcome of this study is lens comfort on a scale of 0-100 (0= worst, 100=best).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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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.
Jill Woods, MSc, MCOptom principal investigator
Centre of Ocular Research and 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 Test Lens (stenfilcon A) in people with Ametropia and Myopia, run by CooperVision International Limited (CVIL) 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 6 inclusion and 6 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 8 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Rating (time frame: At the end of 15 minutes of daily wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.