Back to resultsClinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal (INNOVATION)
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BIOFINITY® MF - AIR OPTIX® AQUA MF
BIOFINITY® MF - PUREVISION® MF
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIOFINITY® MF - AIR OPTIX® AQUA MF
BIOFINITY® MF - PUREVISION® MF
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01591499
Brief Title
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
Acronym
INNOVATION
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOFINITY® MF - AIR OPTIX® AQUA MF
Arm Type
Experimental
Arm Description
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)
Arm Title
BIOFINITY® MF - PUREVISION® MF
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
BIOFINITY® MF - AIR OPTIX® AQUA MF
Other Intervention Name(s)
BIOFINITY® MULTIFOCAL, AIR OPTIX® AQUA MULTIFOCAL
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
BIOFINITY® MF - PUREVISION® MF
Other Intervention Name(s)
BIOFINITY® MULTIFOCAL, PUREVISION® MULTIFOCAL
Intervention Description
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)
Primary Outcome Measure Information:
Title
Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
Description
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
Time Frame
Change over time measured at V1, V3 and V5
Secondary Outcome Measure Information:
Title
Visual Performance - Near Visual Acuity
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance - Distance Visual Acuity
Description
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
Time Frame
Measure at V3 or V5
Title
Visual Performance - Quality of Near Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance - Quality of Intermediate Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance - Quality of Distance Vision
Description
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
Time Frame
Measured at 17-24 days V3 or V5
Title
Visual Performance - Near, Low Contrast Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance: Near, High Contrast Vision
Description
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
Time Frame
Measured at 17-24 days V3 or V5
Title
Visual Performance: Distance, Low Contrast Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance: Distance, High Contrast Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Visual Performance - Near Stereoscopic Vision
Description
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
Time Frame
Measured at V3 or V5
Title
Subjective Rating of Lens Comfort, Fitting
Description
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
Time Frame
Measured at V3 or V5
Title
Subjective Rating of Lens Comfort - During Day
Description
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
Time Frame
Measured at V3 or V5
Title
Subjective Rating of Lens Comfort - End of Day
Description
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
Time Frame
Measured at V3 or V5
Title
Subjective Rating of Lens Comfort - General Comfort
Description
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
Time Frame
Measured at V3 or V5
Title
Comfort of Use - Average Wearing Time
Description
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)
Time Frame
Measured at V3 or V5
Title
Geometric Performance - Lens Centration
Description
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
Time Frame
Measured at V3 or V5
Title
Geometric Performance - Lens Mobility
Description
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
Time Frame
Measured at 17-24 days V3 or V5
Title
Clinical Performance - Lens Wettability
Description
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
Time Frame
Measured at 17-24 days V3 or V5
Title
Lens Preference - Participant
Description
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.
Time Frame
Measured at V5
Title
Lens Preference - Ophthalmologist
Description
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.
Time Frame
Measured at 17-24 days V3 or V5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine Cheneau
Organizational Affiliation
Coopervision, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caroline Bonneville
Organizational Affiliation
Coopervision, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine Peyre
Organizational Affiliation
Catherine Peyre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
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