PresbyopiaNCT06328660
Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens
A study testing Lens 1 and Lens 2 in people with Presbyopia, run by CooperVision International Limited (CVIL) at 1 site in United Kingdom.
Trial summary
The purpose of this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Lens 1 and Lens 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2024to 21 May 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years and older;
- Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);
- Spectacle refraction:
- Distance: Sphere: -6.00D to + 4.00D
- Astigmatism: 0.00D to -0.75D
- Near Addition: Low +0.75D to +1.25D; Medium +1.50D and +1.75D; High +2.00D to +2.50D
- Best corrected visual acuity of at least 20/25 in each eye. - The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
Who cannot join
- To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:
- 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 that would contraindicate contact lens wear;
- Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
- Severe insufficiency of lacrimal secretion (dry eyes).
- Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema).
Show all 14Show fewer
- Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
- Any active corneal infection (bacterial, fungal, protozoal or viral).
- Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops 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 contact 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, 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 corneal refractive surgery
- Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- Current wearer of the test contact lens, MyDay® Multifocal.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ocular Technology Group - International
London, SW1E6AU
About this study
Official title: Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses
The purpose of this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.
Read the detailed description
This was an interventional, prospective, open label, sequential design study. Participants wore each study contact lens on a daily disposable wearing modality for 14 ± 3 days and attended the clinic for a total of three study visits.
- Conditions
- Presbyopia
- Being tested
- Lens 1, Lens 2
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens 1Device
Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality
Lens 2Device
Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality
| Study group | Role | What they receive |
|---|---|---|
| Lens 1 | Experimental | All participants wore Lens 1 for 14 ± 3 days (Period 1) Receives: Device: Lens 1 |
| Lens 2 | Experimental | All participants wore Lens 2 for 14 ± 3 days (Period 2) Receives: Device: Lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Lens Handling
The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses
Measured: 1 week
Secondary outcomes (3)
Overall logMAR Visual Acuity - Dominant Eye
The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.
Measured: 14 days
Overall logMAR Visual Acuity - Non-Dominant Eye
The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.
Measured: 14 days
Overall logMAR Visual Acuity - Binocular
The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Feb 2024
- Primary completion21 May 2024
- Study completion21 May 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 PresbyopiaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Guillon, PhD FCOptom, Principal investigator, mguillon@otg.co.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328660
- Sponsor's protocol ID
- EX-MKTG-155
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2024
- Last updated
- 28 Jul 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT06328660
- Acronym / sponsor ID
- EX-MKTG-155
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Posted 17 Jul 2025
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 this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.
Detailed description
This was an interventional, prospective, open label, sequential design study. Participants wore each study contact lens on a daily disposable wearing modality for 14 ± 3 days and attended the clinic for a total of three study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens 1 | Experimental | Device: Lens 1All participants wore Lens 1 for 14 ± 3 days (Period 1) |
| Lens 2 | Experimental | Device: Lens 2All participants wore Lens 2 for 14 ± 3 days (Period 2) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 years and older;
- Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);
- Spectacle refraction:
- Best corrected visual acuity of at least 20/25 in each eye. - The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
Key exclusion criteria (14 listed)
- To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:
- 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 that would contraindicate contact lens wear;
- Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
- Severe insufficiency of lacrimal secretion (dry eyes).
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 1Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality | Device | Lens 1 |
| Lens 2Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality | Device | Lens 2 |
Primary outcome
Overall Lens Handling
Time frame: 1 week
The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses
3 secondary outcomes
Overall logMAR Visual Acuity - Dominant Eye
Time frame: 14 days
Overall logMAR Visual Acuity - Non-Dominant Eye
Time frame: 14 days
Overall logMAR Visual Acuity - Binocular
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
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 FCOptom principal investigator
mguillon@otg.co.uk
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 and Lens 2 in people with Presbyopia, run by CooperVision International Limited (CVIL) 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 7 inclusion and 14 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 28 Jul 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 17 Jul 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 Lens Handling (time frame: 1 week). 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 28 Jul 2025.