AstigmatismNCT06438601
A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses
A study testing Lens A (omafilcon A) and Lens B (comfilcon A) in people with Astigmatism and Presbyopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
This study aims to compare the short-term clinical performance of the two study contact lenses. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Astigmatism, Presbyopia
- What is being tested?
- Lens A (omafilcon A) and Lens B (comfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2024to 15 Aug 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are aged 35 years or over and have capacity to volunteer.
- They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They are currently wearing soft contact lenses or have done so within the past 12 months.
- They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).
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- They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.
- They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.
- They can be satisfactorily fitted with the study lenses.
- They own a wearable pair of spectacles.
Who cannot join
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medications such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
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- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the short-term clinical performance of the two study contact lenses.
Read the detailed description
The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.
- Conditions
- Astigmatism, Presbyopia
- Being tested
- Lens A (omafilcon A), Lens B (comfilcon A)
- Medical subject headings
- Astigmatism, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (omafilcon A)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 A) | Experimental | All participants will wear lens A for 15 minutes (Period 1). Receives: Device: Lens A (omafilcon A) |
| 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.
Subjective Distance Vision
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
Measured: At the end of 15 minutes of daily wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start24 Apr 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carole Maldonado-Codina, PhD,MCOptom, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438601
- Sponsor's protocol ID
- EX-MKTG-159
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 11 Aug 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06438601
- Acronym / sponsor ID
- EX-MKTG-159
- Conditions
- Astigmatism, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the short-term clinical performance of the two study contact lenses.
Detailed description
The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.
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 A) | Experimental | Device: Lens A (omafilcon A)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
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- They are aged 35 years or over and have capacity to volunteer.
- They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They are currently wearing soft contact lenses or have done so within the past 12 months.
Key exclusion criteria (9 listed)
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medications such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
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 A)15 minutes of daily wear. | Device | Lens A (omafilcon A) |
| Lens B (comfilcon A)15 minutes of daily wear. | Device | Lens B (comfilcon A) |
Primary outcome
Subjective Distance Vision
Time frame: At the end of 15 minutes of daily wear
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
Carole Maldonado-Codina, PhD,MCOptom principal investigator
Eurolens Research
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 A) and Lens B (comfilcon A) in people with Astigmatism and Presbyopia, 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 9 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 11 Aug 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 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?
Yes. Results are posted in the registry (first posted 11 Aug 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?
Subjective Distance Vision (time frame: At the end of 15 minutes of daily 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 11 Aug 2025.