PresbyopiaNCT02719366
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
A study testing comfilcon A Extended Range test lens in people with Presbyopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- comfilcon A Extended Range test lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2016
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Has had a self-reported oculo-visual examination in the last two years
- Is 50 years of age or greater and has full legal capacity to volunteer
- Is able to read and understand the informed consent
- Is willing and able to follow instructions and maintain the appointment schedule
- Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
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- Near Add Power requirement of +2.25D or greater
- Has spectacle cylinder 0.75 D in both eyes
- Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
- Has clear corneas and no active ocular disease
- Has not worn gas permeable contact lenses for 1 month prior to the study
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 abnormality that would affect the wearing of contact lenses
- Is aphakic (i.e. missing their natural lens inside their eye)
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- Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
- 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 Research Center, University of California, Berkeley
Berkeley, California, 94704
About this study
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Read the detailed description
This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
- Conditions
- Presbyopia
- Being tested
- comfilcon A Extended Range test lens, comfilcon A control lens
- 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 Extended Range test lensDevice
contact lenses
comfilcon A control lensDevice
contact lenses
| Study group | Role | What they receive |
|---|---|---|
| comfilcon A Extended Range test lens | Experimental | Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. Receives: Device: comfilcon A Extended Range test lens; Device: comfilcon A control lens |
| comfilcon A control lens | Active comparator | Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. Receives: Device: comfilcon A Extended Range test lens; Device: comfilcon A control lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.
Measured: 4 days
Visual Performance
Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
Measured: 4 days
Secondary outcomes (15)
Comfort
Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Measured: Baseline
Comfort
Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Measured: 4 days
Dryness
Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Measured: Baseline
Dryness
Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Measured: 4 days
Subjective Preference for Comfort
Subjective preference for comfort for test and control contact lenses.
Measured: 4 days
Subjective Satisfaction
Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Measured: 4 days
Subjective Preference for Near Vision
Subjective preference for Near Vision for test and control contact lenses.
Measured: 4 days
Subjective Preference for Intermediate Vision
Subjective preference for intermediate vision for test and control contact lenses.
Measured: 4 days
Subjective Preference for Distance Vision
Subjective preference for distance vision for test and control contact lenses.
Measured: 4 days
Subjective Overall Vision Preference
Subjective overall vision preference for test and control contact lenses.
Measured: 4 days
Average Daily Wearing Time
Average daily wearing time for test and control lens is assessed in hours.
Measured: 4 days
Lens Fit
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit.
Measured: 4 days
Lens Handling
Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle).
Measured: 4 Days
Bulbar Hyperemia
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia
Measured: 4 days
Limbal Hyperemia
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia
Measured: 4 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 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionAug 2016
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meng C Lin, PhD, Study director, CRC, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719366
- Sponsor's protocol ID
- CV-16-07
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2016
- Last updated
- 30 Jul 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 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
- ClinicalTrials.gov ID
- NCT02719366
- Acronym / sponsor ID
- CV-16-07
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 21 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Detailed description
This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comfilcon A Extended Range test lens | Experimental | Device: comfilcon A Extended Range test lens, Device: comfilcon A control lensSubjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
| comfilcon A control lens | Active comparator | Device: comfilcon A Extended Range test lens, Device: comfilcon A control lensSubjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has had a self-reported oculo-visual examination in the last two years
- Is 50 years of age or greater and has full legal capacity to volunteer
- Is able to read and understand the informed consent
- Is willing and able to follow instructions and maintain the appointment schedule
- Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
Key exclusion criteria (9 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 abnormality that would affect the wearing of contact lenses
- Is aphakic (i.e. missing their natural lens inside their eye)
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 Extended Range test lenscontact lenses | Device | comfilcon A Extended Range test lens, comfilcon A control lens |
| comfilcon A control lenscontact lenses | Device | comfilcon A Extended Range test lens, comfilcon A control lens |
Primary outcome
Visual Acuity
Time frame: 4 days
Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.
Visual Performance
Time frame: 4 days
Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
15 secondary outcomes
Comfort
Time frame: Baseline
Comfort
Time frame: 4 days
Dryness
Time frame: Baseline
Dryness
Time frame: 4 days
Subjective Preference for Comfort
Time frame: 4 days
Subjective Satisfaction
Time frame: 4 days
Subjective Preference for Near Vision
Time frame: 4 days
Subjective Preference for Intermediate Vision
Time frame: 4 days
Subjective Preference for Distance Vision
Time frame: 4 days
Subjective Overall Vision Preference
Time frame: 4 days
Average Daily Wearing Time
Time frame: 4 days
Lens Fit
Time frame: 4 days
Lens Handling
Time frame: 4 Days
Bulbar Hyperemia
Time frame: 4 days
Limbal Hyperemia
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
Meng C Lin, PhD study director
CRC, UC Berkeley
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 Extended Range test lens 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 12 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 30 Jul 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 21 Jul 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: 4 days). The study lists 2 primary outcomes in all. 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 30 Jul 2020.