PresbyopiaINNOVATIONNCT01591499
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
A study testing BIOFINITY® MF - AIR OPTIX® AQUA MF and BIOFINITY® MF - PUREVISION® MF in people with Presbyopia, run by CooperVision, Inc..
Trial summary
This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- BIOFINITY® MF - AIR OPTIX® AQUA MF and BIOFINITY® MF - PUREVISION® MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, aged 18 years or older
- Patients with proven presbyopia
- Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
- Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
- Patient able to fill in a diary without help
- Patients who gave their informed consent to take part in the study
Who cannot join
- Patients with a contra-indication for wearing contact lenses
- Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
- Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
- Astigmatic patients whose cylinder is more than 0.75 D
About this study
Official title: Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)
This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Read the detailed description
This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Each subject will have 5 visits with the investigator:
- (V1) An inclusion visit during which the first pair of lenses are fitted;
- (V2) An optimization visit after 7 to 9 days of wearing the first lens;
- (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
- (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.
- Conditions
- Presbyopia
- Being tested
- BIOFINITY® MF - AIR OPTIX® AQUA MF, BIOFINITY® MF - PUREVISION® MF
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOFINITY® MF - AIR OPTIX® AQUA MFDevice
Also called BIOFINITY® MULTIFOCAL, AIR OPTIX® AQUA MULTIFOCAL
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
BIOFINITY® MF - PUREVISION® MFDevice
Also called BIOFINITY® MULTIFOCAL, PUREVISION® MULTIFOCAL
During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
| Study group | Role | What they receive |
|---|---|---|
| BIOFINITY® MF - AIR OPTIX® AQUA MF | Experimental | During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) Receives: Device: BIOFINITY® MF - AIR OPTIX® AQUA MF; Device: BIOFINITY® MF - PUREVISION® MF |
| BIOFINITY® MF - PUREVISION® MF | Active comparator | During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) Receives: Device: BIOFINITY® MF - AIR OPTIX® AQUA MF; Device: BIOFINITY® MF - PUREVISION® MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).
Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):
V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Change over time measured at V1, V3 and V5
Secondary outcomes (20)
Visual Performance - Near Visual Acuity
Description: The participant's near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance - Distance Visual Acuity
Description: The participant's distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measure at V3 or V5
Visual Performance - Quality of Near Vision
Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance - Quality of Intermediate Vision
Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance - Quality of Distance Vision
Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at 17-24 days V3 or V5
Visual Performance - Near, Low Contrast Vision
The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance: Near, High Contrast Vision
The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at 17-24 days V3 or V5
Visual Performance: Distance, Low Contrast Vision
The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance: Distance, High Contrast Vision
The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Visual Performance - Near Stereoscopic Vision
The mean number of occurrences where the "number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9)," performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Subjective Rating of Lens Comfort, Fitting
Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Subjective Rating of Lens Comfort - During Day
Patients' subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Subjective Rating of Lens Comfort - End of Day
Patients' subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Subjective Rating of Lens Comfort - General Comfort
Patients' subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Comfort of Use - Average Wearing Time
The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients' subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)
Measured: Measured at V3 or V5
Geometric Performance - Lens Centration
Description: The ophthalmologist's rating of lens centration during "Focus" and "Shift When Blinking" by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at V3 or V5
Geometric Performance - Lens Mobility
The ophthalmologist's rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at 17-24 days V3 or V5
Clinical Performance - Lens Wettability
The ophthalmologist's rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
Measured: Measured at 17-24 days V3 or V5
Lens Preference - Participant
The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.("Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.
Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days.
Measured: Measured at V5
Lens Preference - Ophthalmologist
Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. ("Choice of Lens? First pair of lenses, Second pair of lenses") (Biofinity, Air Optix, or Purevision)
Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days.
Measured: Measured at 17-24 days V3 or V5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionSep 2012
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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandrine Cheneau, Study director, CooperVision, Inc.Caroline Bonneville, Study director, CooperVision, Inc.Catherine Peyre, Principal investigator, Catherine Peyre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591499
- Sponsor's protocol ID
- 2011-A00886-35
- Acronym
- INNOVATION
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2012
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)
- ClinicalTrials.gov ID
- NCT01591499
- Acronym / sponsor ID
- INNOVATION / 2011-A00886-35
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 8 Feb 2016
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 prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Detailed description
This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.
Each subject will have 5 visits with the investigator:
- (V1) An inclusion visit during which the first pair of lenses are fitted;
- (V2) An optimization visit after 7 to 9 days of wearing the first lens;
- (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
- (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIOFINITY® MF - AIR OPTIX® AQUA MF | Experimental | Device: BIOFINITY® MF - AIR OPTIX® AQUA MF, Device: BIOFINITY® MF - PUREVISION® MFDuring the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) |
| BIOFINITY® MF - PUREVISION® MF | Active comparator | Device: BIOFINITY® MF - AIR OPTIX® AQUA MF, Device: BIOFINITY® MF - PUREVISION® MFDuring the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients, aged 18 years or older
- Patients with proven presbyopia
- Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
- Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
- Patient able to fill in a diary without help
Key exclusion criteria (4 listed)
- Patients with a contra-indication for wearing contact lenses
- Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
- Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
- Astigmatic patients whose cylinder is more than 0.75 D
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 |
|---|---|---|
| BIOFINITY® MF - AIR OPTIX® AQUA MFAlso: BIOFINITY® MULTIFOCAL, AIR OPTIX® AQUA MULTIFOCALDuring the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) | Device | BIOFINITY® MF - AIR OPTIX® AQUA MF, BIOFINITY® MF - PUREVISION® MF |
| BIOFINITY® MF - PUREVISION® MFAlso: BIOFINITY® MULTIFOCAL, PUREVISION® MULTIFOCALDuring the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity) | Device | BIOFINITY® MF - AIR OPTIX® AQUA MF, BIOFINITY® MF - PUREVISION® MF |
Primary outcome
Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
Time frame: Change over time measured at V1, V3 and V5
The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5). Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation): V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two
20 secondary outcomes
Visual Performance - Near Visual Acuity
Time frame: Measured at V3 or V5
Visual Performance - Distance Visual Acuity
Time frame: Measure at V3 or V5
Visual Performance - Quality of Near Vision
Time frame: Measured at V3 or V5
Visual Performance - Quality of Intermediate Vision
Time frame: Measured at V3 or V5
Visual Performance - Quality of Distance Vision
Time frame: Measured at 17-24 days V3 or V5
Visual Performance - Near, Low Contrast Vision
Time frame: Measured at V3 or V5
Visual Performance: Near, High Contrast Vision
Time frame: Measured at 17-24 days V3 or V5
Visual Performance: Distance, Low Contrast Vision
Time frame: Measured at V3 or V5
Visual Performance: Distance, High Contrast Vision
Time frame: Measured at V3 or V5
Visual Performance - Near Stereoscopic Vision
Time frame: Measured at V3 or V5
Subjective Rating of Lens Comfort, Fitting
Time frame: Measured at V3 or V5
Subjective Rating of Lens Comfort - During Day
Time frame: Measured at V3 or V5
Subjective Rating of Lens Comfort - End of Day
Time frame: Measured at V3 or V5
Subjective Rating of Lens Comfort - General Comfort
Time frame: Measured at V3 or V5
Comfort of Use - Average Wearing Time
Time frame: Measured at V3 or V5
Geometric Performance - Lens Centration
Time frame: Measured at V3 or V5
Geometric Performance - Lens Mobility
Time frame: Measured at 17-24 days V3 or V5
Clinical Performance - Lens Wettability
Time frame: Measured at 17-24 days V3 or V5
Lens Preference - Participant
Time frame: Measured at V5
Lens Preference - Ophthalmologist
Time frame: Measured at 17-24 days V3 or V5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- 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.
Sandrine Cheneau study director
CooperVision, Inc.
Caroline Bonneville study director
CooperVision, Inc.
Catherine Peyre principal investigator
Catherine Peyre
Questions about this trial
What is this clinical trial studying?
A study testing BIOFINITY® MF - AIR OPTIX® AQUA MF and BIOFINITY® MF - PUREVISION® MF in people with Presbyopia, run by CooperVision, Inc..
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 6 inclusion and 4 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 8 Feb 2016). 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 Performance - Comparison of Initial Refraction to Multifocal Lenses (time frame: Change over time measured at V1, V3 and V5). 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 11 Aug 2020.