AstigmatismNCT06431061
Clinical Evaluation of Proclear Toric and Biofinity Toric
A study testing Lens A (omafilcon B) and Lens B (comfilcon A) in people with Astigmatism, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The aim of this study is to compare the short-term clinical performance of two Toric contact lenses. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Lens A (omafilcon B) and Lens B (comfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2024to 13 Nov 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are at least 17 years of age and has full legal capacity to volunteer.
- Have understood and signed an information consent letter.
- Are willing and able to follow instructions and maintain the appointment schedule.
- Are an adapted soft toric contact lens wearer.
- Do not habitually wear either of the two study lens types.
- Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
- Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
- Can be fitted with and achieve a distance visual acuity of +0.18 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 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Have a history of not achieving comfortable CL use (5 days per week; > 8 hours/day)
- 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 compare the short-term clinical performance of two Toric contact lenses.
Read the detailed description
The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.
- Conditions
- Astigmatism
- Being tested
- Lens A (omafilcon B), Lens B (comfilcon A)
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (omafilcon B)Device
15 minutes of daily wear.
Lens B (comfilcon A)Device
15 minutes of daily wear.
| Study group | Role | What they receive |
|---|---|---|
| Lens A (omafilcon B) | Experimental | All participants will wear lens A for 15 minutes (Period 1). Receives: Device: Lens A (omafilcon B) |
| Lens B (comfilcon A) | Experimental | All participants will wear lens B for 15 minutes (Period 2). Receives: Device: Lens B (comfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Fit Acceptance
Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)
Measured: After 15 minutes of continuous wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start4 Jun 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 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 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
- 37 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, Principal investigator, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431061
- Sponsor's protocol ID
- EX-MKTG-158
- Status last verified
- Aug 2025
- First submitted
- 22 May 2024
- Last updated
- 15 Sep 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Proclear Toric and Biofinity Toric
- ClinicalTrials.gov ID
- NCT06431061
- Acronym / sponsor ID
- EX-MKTG-158
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Posted 15 Sep 2025
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 compare the short-term clinical performance of two Toric contact lenses.
Detailed description
The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens A (omafilcon B) | Experimental | Device: Lens A (omafilcon B)All participants will wear lens A for 15 minutes (Period 1). |
| Lens B (comfilcon A) | Experimental | Device: Lens B (comfilcon A)All participants will wear lens B for 15 minutes (Period 2). |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are at least 17 years of age and has full legal capacity to volunteer.
- Have understood and signed an information consent letter.
- Are willing and able to follow instructions and maintain the appointment schedule.
- Are an adapted soft toric contact lens wearer.
- Do not habitually wear either of the two study lens types.
Key exclusion criteria (7 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 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 known sensitivity to the diagnostic pharmaceuticals 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 A (omafilcon B)15 minutes of daily wear. | Device | Lens A (omafilcon B) |
| Lens B (comfilcon A)15 minutes of daily wear. | Device | Lens B (comfilcon A) |
Primary outcome
Overall Fit Acceptance
Time frame: After 15 minutes of continuous wear
Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- 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 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 A (omafilcon B) and Lens B (comfilcon A) in people with Astigmatism, 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 8 inclusion and 7 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 Sep 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?
Yes. Results are posted in the registry (first posted 15 Sep 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?
Overall Fit Acceptance (time frame: After 15 minutes of continuous 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 Sep 2025.