AstigmatismNCT06873048
Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism
A study testing Test Contact Lens (stenfilcon A Toric) in people with Astigmatism and Myopia, run by CooperVision International Limited (CVIL) at 1 site in Canada.
Trial summary
The primary objective of the study is to evaluate and compare the performance of two soft contact lens. Read more about this study
- Who is it for?
- Ages 17 to 42 years
- Conditions the study is for
- Astigmatism, Myopia, Hyperopia
- What is being tested?
- Test Contact Lens (stenfilcon A Toric)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2025to 11 Jul 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 17 to 42 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- At least 17 years and no more than 42 years of age.
- Have read and signed the study consent form.
- Are willing and able to follow instructions and maintain the appointment schedule.
- Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
- Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
- Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
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- Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
- Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
- Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
- Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
- Demonstrate an acceptable fit with the study contact lenses.
Who cannot join
- Are participating in any concurrent clinical interventional study.
- Have worn rigid contact lenses in the last 3 months.
- Have worn soft toric contact lenses in the past 3 months.
- Have any known active ocular disease or allergies and/or infection.
- Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
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- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
- Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
- Have undergone refractive error surgery or intraocular surgery.
- Are an employee of the Centre for Ocular Research \& Education directly involved in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)
The primary objective of the study is to evaluate and compare the performance of two soft contact lens.
Read the detailed description
The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.
- Conditions
- Astigmatism, Myopia, Hyperopia
- Being tested
- Control Contact Lens (stenfilcon A Sphere), Test Contact Lens (stenfilcon A Toric)
- Medical subject headings
- Astigmatism, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Contact Lens (stenfilcon A Sphere)Device
One week of wear
Test Contact Lens (stenfilcon A Toric)Device
One week of wear
| Study group | Role | What they receive |
|---|---|---|
| Control Contact Lens (stenfilcon A Sphere) | Experimental | All participants will wear Control Contact Lens for one week (Period 1). Receives: Device: Control Contact Lens (stenfilcon A Sphere) |
| Test Contact Lens (stenfilcon A Toric) | Experimental | All participants will wear Test Contact Lens for one week (Period 2). Receives: Device: Test Contact Lens (stenfilcon A Toric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Comfort
Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 100=best)
Measured: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start26 Feb 2025
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- 32 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
- Lyndon Jones, PhD,FCOptom, Principal investigator, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873048
- Sponsor's protocol ID
- CV-24-42
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 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
- Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)
- ClinicalTrials.gov ID
- NCT06873048
- Acronym / sponsor ID
- CV-24-42
- Conditions
- Astigmatism, Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 12 Mar 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 primary objective of the study is to evaluate and compare the performance of two soft contact lens.
Detailed description
The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Contact Lens (stenfilcon A Sphere) | Experimental | Device: Control Contact Lens (stenfilcon A Sphere)All participants will wear Control Contact Lens for one week (Period 1). |
| Test Contact Lens (stenfilcon A Toric) | Experimental | Device: Test Contact Lens (stenfilcon A Toric)All participants will wear Test Contact Lens for one week (Period 2). |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- At least 17 years and no more than 42 years of age.
- Have read and signed the study consent form.
- Are willing and able to follow instructions and maintain the appointment schedule.
- Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
- Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
Key exclusion criteria (10 listed)
- Are participating in any concurrent clinical interventional study.
- Have worn rigid contact lenses in the last 3 months.
- Have worn soft toric contact lenses in the past 3 months.
- Have any known active ocular disease or allergies and/or infection.
- Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
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 Contact Lens (stenfilcon A Sphere)One week of wear | Device | Control Contact Lens (stenfilcon A Sphere) |
| Test Contact Lens (stenfilcon A Toric)One week of wear | Device | Test Contact Lens (stenfilcon A Toric) |
Primary outcome
Contact Lens Comfort
Time frame: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear
Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 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.
Lyndon Jones, PhD,FCOptom principal investigator
Centre for 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 Contact Lens (stenfilcon A Toric) in people with Astigmatism 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 11 inclusion and 10 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?
Contact Lens Comfort (time frame: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens 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.