MyopiaNCT06609018
Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses
A study testing Test Lenses (stenfilcon A) in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to compare clinical performance between two 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
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2024to 5 Mar 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.
- Have experience with soft contact lens wear and able to insert and remove soft contact lenses.
- Parent/guardian and participant have read and understood the Participant Information Sheet.
- Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).
- Best corrected visual acuity of at least 20/25 in each eye.
- Have normal eyes with the exception of the need for visual correction.
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- Spectacle refraction:
- Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of <1.00D
- Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of <1.00D.
- Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
Who cannot join
- Acute and subacute inflammation or infection of the anterior chamber of the eye.
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
- Severe insufficiency of lacrimal secretion (dry eyes).
- Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
- Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
- Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
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- Any active corneal infection (bacterial, fungal, or viral).
- The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
- Newly prescribed use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
- Monocular participants (only one eye with functional vision) or participants fit with only one lens.
- Subjects with slit lamp findings greater than grade 1 (e.g., edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980:2012, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit.
- History of herpetic keratitis, ocular surgery or irregular cornea.
- Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ocular Technology Group - International
London, SW1E 6AU
About this study
The purpose of the study is to compare clinical performance between two soft contact lenses.
Read the detailed description
The purpose of this study is to compare clinical performance of two soft contact lenses in a crossover study over a period of 7 days of wear.
- 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.
Total Absolute Decentration
Total absolute decentration from pupil centre in mm at one-week follow-up visits after at least three hours of wear. Decentration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration , 1 = acceptable decentration and 2= unacceptable decentration.
Measured: At the end of one week daily disposable wear, after at least three hours of wear.
Contact Lens Centration
Contact lens centration clinical rating at one-week follow-up visits after at least three hours of wear. Centration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration, 1 = acceptable decentration and 2= unacceptable decentration.
Measured: At the end of one week daily disposable wear, after at least three hours of wear.
Contact Lens Movement
Contact lens movement at blink clinical rating at one-week follow-up visits after at least three hours of wear. Contact Lens Movement will be recorded:
- for the eye in the primary position immediately after the blink;
- for the recovery movement following digitally applied lower lid margin push-up with the lower lid as follows: (-2) = reduced movement unacceptable (-1) = reduced movement acceptable (0) = optimal movement (+1) = excessive movement acceptable (+2) = excessive movement unacceptable
Measured: At the end of one week daily disposable wear, after at least three hours of wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Aug 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
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
- Model description
- Study includes a second phase (Parallel) that has no primary or secondary outcome measures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Guillon, PhD, Principal investigator, Ocular Technology Group- International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609018
- Sponsor's protocol ID
- CV-23-02
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2024
- Last updated
- 24 Feb 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06609018
- Acronym / sponsor ID
- CV-23-02
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 23 Sep 2024 (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 purpose of the study is to compare clinical performance between two soft contact lenses.
Detailed description
The purpose of this study is to compare clinical performance of two soft contact lenses in a crossover study over a period of 7 days of wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study includes a second phase (Parallel) that has no primary or secondary outcome measures.
| 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 (10 listed)
- Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.
- Have experience with soft contact lens wear and able to insert and remove soft contact lenses.
- Parent/guardian and participant have read and understood the Participant Information Sheet.
- Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).
- Best corrected visual acuity of at least 20/25 in each eye.
Key exclusion criteria (13 listed)
- Acute and subacute inflammation or infection of the anterior chamber of the eye.
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
- Severe insufficiency of lacrimal secretion (dry eyes).
- Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
- Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
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
Total Absolute Decentration
Time frame: At the end of one week daily disposable wear, after at least three hours of wear.
Total absolute decentration from pupil centre in mm at one-week follow-up visits after at least three hours of wear. Decentration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration , 1 = acceptable decentration and 2= unacceptable decentration.
Contact Lens Centration
Time frame: At the end of one week daily disposable wear, after at least three hours of wear.
Contact lens centration clinical rating at one-week follow-up visits after at least three hours of wear. Centration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration, 1 = acceptable decentration and 2= unacceptable decentration.
Contact Lens Movement
Time frame: At the end of one week daily disposable wear, after at least three hours of wear.
Contact lens movement at blink clinical rating at one-week follow-up visits after at least three hours of wear. Contact Lens Movement will be recorded: a) for the eye in the primary position immediately after the blink; b) for the recovery movement following digitally applied lower lid margin push-up with the lower lid as follows: (-2) = reduced movement unacceptable (-1) = reduced movement acceptable (0) = optimal movement (+1) = excessive movement acceptable (+2) = excessive movement unacceptable
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 24 Feb 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.
Michel Guillon, PhD principal investigator
Ocular Technology Group- International
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 Kingdom.
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 10 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 24 Feb 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 United Kingdom. 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?
Total Absolute Decentration (time frame: At the end of one week daily disposable wear, after at least three hours of wear.). The study lists 3 primary outcomes in all. 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 24 Feb 2026.