PresbyopiaNCT03417557
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
A study testing Comfilcon A lens (test) in people with Presbyopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Comfilcon A lens (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 3 Apr 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 between ages 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the information consent letter. 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).
- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
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- Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
Who cannot join
- A person will be excluded from the study if he/she:
- 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 affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
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- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405
About this study
Official title: Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Read the detailed description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
- Conditions
- Presbyopia
- Being tested
- Comfilcon A lens (test), Omafilcon B lens (control)
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfilcon A lens (test)Device
Also called Biofinity multifocal toric Lens (test)
contact lens
Omafilcon B lens (control)Device
Also called Proclear multifocal toric lens (control)
contact lens
| Study group | Role | What they receive |
|---|---|---|
| Comfilcon A lens (test) | Experimental | Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. Receives: Device: Comfilcon A lens (test) |
| Omafilcon B Lens (control) | Active comparator | Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. Receives: Device: Omafilcon B lens (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity is assessed for test and control lens on a logMAR chart
Measured: up to 3 hours
Secondary outcomes (3)
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Measured: up to 3 hours
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Measured: up to 3 hours
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start12 Jan 2018
- Primary completion3 Apr 2018
- Study completion3 Apr 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
- Model description
- This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417557
- Sponsor's protocol ID
- CV-18-10
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 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 Validation Study of Biofinity Multifocal Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT03417557
- Acronym / sponsor ID
- CV-18-10
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 31 Jan 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 is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
| Arm | Type | Receives |
|---|---|---|
| Comfilcon A lens (test) | Experimental | Device: Comfilcon A lens (test)Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. |
| Omafilcon B Lens (control) | Active comparator | Device: Omafilcon B lens (control)Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has had a self-reported oculo-visual examination in the last two years.
- Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the information consent letter. 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).
Key exclusion criteria (10 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 affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
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 lens (test)Also: Biofinity multifocal toric Lens (test)contact lens | Device | Comfilcon A lens (test) |
| Omafilcon B lens (control)Also: Proclear multifocal toric lens (control)contact lens | Device | Omafilcon B Lens (control) |
Primary outcome
Visual Acuity
Time frame: up to 3 hours
Visual acuity is assessed for test and control lens on a logMAR chart
3 secondary outcomes
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Time frame: up to 3 hours
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Time frame: up to 3 hours
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Time frame: up to 3 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.
The record lists no contact. Use the official record to reach the sponsor.
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 lens (test) in people with Presbyopia, run by CooperVision, Inc. at 1 site in United States.
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 11 inclusion and 10 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 States. 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 3 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.