MyopiaNCT06817785
Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
A study testing Lens 1 (ocufilcon D) and Lens 2 (somofilcon A) in people with Myopia, run by CooperVision, Inc. 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
- Conditions the study is for
- Myopia
- What is being tested?
- Lens 1 (ocufilcon D) and Lens 2 (somofilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2025to 25 Feb 2025
- 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 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 full legal capacity to volunteer;
- Have understood and signed an information consent letter;
- Are willing and able to maintain the appointment schedule;
- Are an adapted soft contact lens wearer;
- Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
- Have a refraction with a cylinder component of no more than -1.00DC in each eye;
- Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.
Who cannot join
- Are participating in any concurrent clinical or research study;
- Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
- Have a systemic condition that would contraindicate contact lens use;
- Are using any systemic or topical medications that would contraindicate contact lens use;
- Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
- Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. 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 myopic soft lens wearers.
- Conditions
- Myopia
- Being tested
- Lens 1 (ocufilcon D), Lens 2 (somofilcon A)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens 1 (ocufilcon D)Device
15 minutes of daily wear
Lens 2 (somofilcon A)Device
15 minutes of daily wear
| Study group | Role | What they receive |
|---|---|---|
| Lens 1 (ocufilcon D) | Experimental | All participants will wear lens 1 for 15 minutes (Period 1). Receives: Device: Lens 1 (ocufilcon D) |
| Lens 2 (somofilcon A) | Experimental | All participants will wear lens 2 for 15 minutes (Period 2). Receives: Device: Lens 2 (somofilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Comfort
The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
Measured: Immediately after lens application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start24 Jan 2025
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- 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
- NCT06817785
- Sponsor's protocol ID
- EX-MKTG-164
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
- ClinicalTrials.gov ID
- NCT06817785
- Acronym / sponsor ID
- EX-MKTG-164
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Posted 31 Aug 2026
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 myopic 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 |
|---|---|---|
| Lens 1 (ocufilcon D) | Experimental | Device: Lens 1 (ocufilcon D)All participants will wear lens 1 for 15 minutes (Period 1). |
| Lens 2 (somofilcon A) | Experimental | Device: Lens 2 (somofilcon A)All participants will wear lens 2 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 (7 listed)
- Are at least 18 years of age and have full legal capacity to volunteer;
- Have understood and signed an information consent letter;
- Are willing and able to maintain the appointment schedule;
- Are an adapted soft contact lens wearer;
- Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
Key exclusion criteria (6 listed)
- Are participating in any concurrent clinical or research study;
- Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
- Have a systemic condition that would contraindicate contact lens use;
- Are using any systemic or topical medications that would contraindicate contact lens use;
- 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 |
|---|---|---|
| Lens 1 (ocufilcon D)15 minutes of daily wear | Device | Lens 1 (ocufilcon D) |
| Lens 2 (somofilcon A)15 minutes of daily wear | Device | Lens 2 (somofilcon A) |
Primary outcome
Lens Comfort
Time frame: Immediately after lens application
The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Lens 1 (ocufilcon D) and Lens 2 (somofilcon 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 7 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 31 Aug 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?
Yes. Results are posted in the registry (first posted 31 Aug 2026). 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?
Lens Comfort (time frame: Immediately after lens application). 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 31 Aug 2026.