MyopiaNCT06170658
1 Week Crossover Dispensing Study Between Two Soft Contact Lenses
A study testing Test Lenses (stenfilcon A) in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Test Lenses (stenfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2023to 21 Aug 2024
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
- Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
- Are willing and able to follow instructions and maintain the appointment schedule;
- Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
- Currently wears spherical soft contact lenses or myopia control soft lenses;
- Have a pair of wearable back-up spectacles;
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- Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
- Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
- Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
- Have clear corneas with no corneal scars or any active ocular disease;
- Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
- Demonstrate an acceptable fit with the study lenses.
- Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;
Who cannot join
- Have taken part in another clinical research study within the last 14 days;
- Are currently habitual wearers of toric lenses.
- Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
- Are an extended lens wearer (i.e., sleeping with their lenses)
- Are on ongoing atropine treatment for myopia control
- Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes;
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- Have amblyopia and/or strabismus/binocular vision problem
- Have any known active ocular disease, allergies and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Have undergone refractive error surgery or intraocular surgery;
- Are a member of CORE directly involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses
The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.
Read the detailed description
This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.
- Conditions
- Myopia
- Being tested
- Test Lenses (stenfilcon A), Control Lenses (omafilcon A)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Lenses (stenfilcon A)Device
Daily disposable, silicone hydrogel investigational lenses for one week
Control Lenses (omafilcon A)Device
Daily disposable, hydrogel commercially available lenses for one week
| Study group | Role | What they receive |
|---|---|---|
| Test Lenses, Then Control Lenses | Experimental | Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week. Receives: Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A) |
| Control Lenses, Then Test Lenses | Experimental | Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week. Receives: Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High contrast, binocular, distance visual acuity
Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.
Measured: 7 days
Secondary outcomes (1)
Subjective Vision Quality
Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start11 Dec 2023
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 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
- NCT06170658
- Sponsor's protocol ID
- CV-23-58
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2023
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06170658
- Acronym / sponsor ID
- CV-23-58
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 14 Dec 2023 (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 objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.
Detailed description
This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Lenses, Then Control Lenses | Experimental | Device: Test Lenses (stenfilcon A), Device: Control Lenses (omafilcon A)Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week. |
| Control Lenses, Then Test Lenses | Experimental | Device: Test Lenses (stenfilcon A), Device: Control Lenses (omafilcon A)Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
- Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
- Are willing and able to follow instructions and maintain the appointment schedule;
- Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
- Currently wears spherical soft contact lenses or myopia control soft lenses;
Key exclusion criteria (13 listed)
- Have taken part in another clinical research study within the last 14 days;
- Are currently habitual wearers of toric lenses.
- Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
- Are an extended lens wearer (i.e., sleeping with their lenses)
- Are on ongoing atropine treatment for myopia control
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 |
|---|---|---|
| Test Lenses (stenfilcon A)Daily disposable, silicone hydrogel investigational lenses for one week | Device | Control Lenses, Then Test Lenses, Test Lenses, Then Control Lenses |
| Control Lenses (omafilcon A)Daily disposable, hydrogel commercially available lenses for one week | Device | Control Lenses, Then Test Lenses, Test Lenses, Then Control Lenses |
Primary outcome
High contrast, binocular, distance visual acuity
Time frame: 7 days
Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.
1 secondary outcome
Subjective Vision Quality
Time frame: 7 days
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 6 Aug 2025.
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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 Test Lenses (stenfilcon 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 13 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 6 Aug 2025. 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?
High contrast, binocular, distance visual acuity (time frame: 7 days). 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 6 Aug 2025.