MyopiaNCT06611410
1 Week Crossover 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 United States.
Trial summary
The objective of this investigation is to compare the visual clinical performance of two daily disposable soft 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 26 Jul 2024
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are 8 to 18 years of age (inclusively)
- Have read, signed and dated:
- Age 18 - The Participant Informed Consent Form (participant only)
- Age 12-17 - The Parental Permission Form (participant and parent)
- Age 8-11 - The Parental Permission Form (parent) and Assent form (participant)
- Are willing and able to follow instructions and maintain the appointment schedule.
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- Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye, including myopia control soft contact lenses as below-
- Currently wears spherical soft contact lenses or myopia control soft contact lenses.
- Have a pair of wearable back-up spectacles.
- 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 contact 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 contact lenses.
- Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days.
- Are an extended contact lens wearer (i.e., sleeping with their contact 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 CORL directly involved in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab (CORL)
Bloomington, Indiana, 47405
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 two daily disposable soft contact lenses.
Read the detailed description
This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.
- 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, soft contact lenses worn for one week.
Control Lenses (omafilcon A)Device
Daily disposable, soft contact lenses worn 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 (logMAR)
High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.
Measured: At the end of one week wear
Secondary outcomes (1)
Subjective Vision Quality
Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good)
Measured: At the end of one week wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start5 Jun 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete S Kollbaum, OD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611410
- Sponsor's protocol ID
- CV-23-59
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2024
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Oct 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
- NCT06611410
- Acronym / sponsor ID
- CV-23-59
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Posted 15 Oct 2025
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 two daily disposable soft contact lenses.
Detailed description
This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.
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 (16 listed)
- Are 8 to 18 years of age (inclusively)
- Have read, signed and dated:
- 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, including myopia control soft contact lenses as below-
- Currently wears spherical soft contact lenses or myopia control soft contact 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 contact lenses.
- Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days.
- Are an extended contact lens wearer (i.e., sleeping with their contact 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, soft contact lenses worn for one week. | Device | Control Lenses, Then Test Lenses, Test Lenses, Then Control Lenses |
| Control Lenses (omafilcon A)Daily disposable, soft contact lenses worn for one week. | Device | Control Lenses, Then Test Lenses, Test Lenses, Then Control Lenses |
Primary outcome
High Contrast, Binocular, Distance Visual Acuity (logMAR)
Time frame: At the end of one week wear
High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.
1 secondary outcome
Subjective Vision Quality
Time frame: At the end of one week wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myopia
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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.
Pete S Kollbaum, OD, PhD principal investigator
Indiana University
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 United States.
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 16 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 15 Oct 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 United States. 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 15 Oct 2025). 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?
High Contrast, Binocular, Distance Visual Acuity (logMAR) (time frame: At the end of one week 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 15 Oct 2025; AzTrials last refreshed its copy on 28 Oct 2026.