PresbyopiaNCT03519282
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
A study testing comfilcon A multifocal toric lens and omafilcon A Multifocal Toric Lens in people with Presbyopia and Astigmatism, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Presbyopia, Astigmatism
- What is being tested?
- comfilcon A multifocal toric lens and omafilcon A Multifocal Toric Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2018to 24 Jul 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has had a self-reported oculo-visual examination in the last two years.
- Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the participant information sheet.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is able to participate in Parts A and B related to this work.
- Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
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- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
- Can be satisfactorily fitted with the study lenses.
- Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
- They have successfully worn soft contact lenses in the last six months
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Has an up-to-date pair of spectacles.
Who cannot join
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
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- Is aphakic.
- Has undergone corneal refractive surgery.
- Has a history of anaphylaxis or severe allergic reaction.
- Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
- They are pregnant or breast-feeding.
- Is participating in any other type of eye-related clinical or research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Read the detailed description
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
- Conditions
- Presbyopia, Astigmatism
- Being tested
- comfilcon A multifocal toric lens, omafilcon A Multifocal Toric Lens
- Medical subject headings
- Presbyopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon A multifocal toric lensDevice
Also called Test Multifocal Toric Lens, Biofinity multifocal toric lens
contact lens
omafilcon A Multifocal Toric LensDevice
Also called Proclear multifocal toric lens, Control multifocal toric lens
contact lens
| Study group | Role | What they receive |
|---|---|---|
| Test Multifocal Toric Lens | Experimental | comfilcon A multifocal toric lens Receives: Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens |
| omafilcon A Multifocal Toric Lens | Active comparator | Control multifocal toric lens Receives: Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual Acuity (measured in LogMAR)
Measured: Up to 2 hours
Secondary outcomes (3)
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Measured: Up to 2 hours
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Measured: Up to 2 hours
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start25 Apr 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, BSc, PhD, MCOptom, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519282
- Sponsor's protocol ID
- CV-18-11
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2018
- Last updated
- 4 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT03519282
- Acronym / sponsor ID
- CV-18-11
- Conditions
- Presbyopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 4 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Detailed description
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Multifocal Toric Lens | Experimental | Device: comfilcon A multifocal toric lens, Device: omafilcon A Multifocal Toric Lenscomfilcon A multifocal toric lens |
| omafilcon A Multifocal Toric Lens | Active comparator | Device: comfilcon A multifocal toric lens, Device: omafilcon A Multifocal Toric LensControl multifocal toric lens |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Has had a self-reported oculo-visual examination in the last two years.
- Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the participant information sheet.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is able to participate in Parts A and B related to this work.
Key exclusion criteria (12 listed)
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation 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 |
|---|---|---|
| comfilcon A multifocal toric lensAlso: Test Multifocal Toric Lens, Biofinity multifocal toric lenscontact lens | Device | Test Multifocal Toric Lens, omafilcon A Multifocal Toric Lens |
| omafilcon A Multifocal Toric LensAlso: Proclear multifocal toric lens, Control multifocal toric lenscontact lens | Device | Test Multifocal Toric Lens, omafilcon A Multifocal Toric Lens |
Primary outcome
Visual Acuity
Time frame: Up to 2 hours
Visual Acuity (measured in LogMAR)
3 secondary outcomes
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
Time frame: Up to 2 hours
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
Time frame: Up to 2 hours
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
Time frame: Up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, BSc, 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 comfilcon A multifocal toric lens and omafilcon A Multifocal Toric Lens in people with Presbyopia and Astigmatism, 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 14 inclusion and 12 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 4 May 2020. 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 4 May 2020). 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?
Visual Acuity (time frame: Up to 2 hours). 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 4 May 2020.