PresbyopiaNCT05794126
A Clinical Comparison of Two Soft Multifocal Contact Lenses
A study testing Lens 1 and Lens 2 in people with Presbyopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses. Read more about this study
- Who is it for?
- Ages 42 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
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to 23 Mar 2023
- 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 42 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They were at least 42 years of age and had capacity to volunteer.
- They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- They had had a full eye examination within the past two years (by self-report).
- They were willing and able to follow the protocol.
- They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
- They had refractive astigmatism of no greater than -0.75DC.
- They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.
Who cannot join
- Subjects were not eligible to take part in the study if:
- They had an ocular disorder which would normally contra-indicate contact lens wear.
- They had a systemic disorder which would normally contra-indicate contact lens wear.
- They were using any topical medication such as eye drops or ointment.
- They were aphakic.
- They had had corneal refractive surgery.
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- They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
- They were pregnant or lactating.
- They had an eye or health condition including an immunosuppressive or infectious disease which could, 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.
Read the detailed description
The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.
- 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
Soft multifocal hydrogel contact lens for 15 minutes
Lens 2Device
Soft multifocal silicone hydrogel contact lens for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lens 1 | Experimental | Participants wore Lens 1 for 15 minutes (Period 1) Receives: Device: Lens 1 |
| Lens 2 | Experimental | Participants wore Lens 2 for 15 minutes (Period 2) Receives: Device: Lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Overall Score
Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall
Measured: 15 Minutes
Secondary outcomes (2)
Subjective Comfort
Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Measured: 15 Minutes
Subjective Vision
Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Feb 2023
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD, MCOptom, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794126
- Sponsor's protocol ID
- C22-726 (EX-MKTG-147)
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2023
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two Soft Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT05794126
- Acronym / sponsor ID
- C22-726 (EX-MKTG-147)
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 10 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.
Detailed description
The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens 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 1 | Experimental | Device: Lens 1Participants wore Lens 1 for 15 minutes (Period 1) |
| Lens 2 | Experimental | Device: Lens 2Participants wore Lens 2 for 15 minutes (Period 2) |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- They were at least 42 years of age and had capacity to volunteer.
- They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- They had had a full eye examination within the past two years (by self-report).
- They were willing and able to follow the protocol.
- They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
Key exclusion criteria (9 listed)
- They had an ocular disorder which would normally contra-indicate contact lens wear.
- They had a systemic disorder which would normally contra-indicate contact lens wear.
- They were using any topical medication such as eye drops or ointment.
- They were aphakic.
- They had 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 1Soft multifocal hydrogel contact lens for 15 minutes | Device | Lens 1 |
| Lens 2Soft multifocal silicone hydrogel contact lens for 15 minutes. | Device | Lens 2 |
Primary outcome
Subjective Overall Score
Time frame: 15 Minutes
Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall
2 secondary outcomes
Subjective Comfort
Time frame: 15 Minutes
Subjective Vision
Time frame: 15 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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.
Philip Morgan, 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 1 and Lens 2 in people with 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 7 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 10 Apr 2024. 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 10 Apr 2024). 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 Overall Score (time frame: 15 Minutes). 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 10 Apr 2024.