Presbyopia
Conditions
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.
Interventions
DEVICEBIOFINITY® MF - AIR OPTIX® AQUA MF
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)
DEVICEBIOFINITY® MF - PUREVISION® MF
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)
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Performance - Comparison of Initial Refraction to Multifocal Lenses | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Performance - Distance Visual Acuity | Measure at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at 17-24 days V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at 17-24 days V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 |
| Visual Performance - Near Visual Acuity | Measured at V3 or V5 | 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 |
| Subjective Rating of Lens Comfort - During Day | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at V3 or V5 | 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 | Measured at 17-24 days V3 or V5 | 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 | Measured at 17-24 days V3 or V5 | 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 | Measured at V5 | 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 | Measured at 17-24 days V3 or V5 | 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. |
| Subjective Rating of Lens Comfort, Fitting | Measured at V3 or V5 | 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 |
Participant flow
Recruitment details
Multi-center study conducted by 15 freelance opthalmologiests to enroll 180 patients.
Participants by arm
| Arm | Count |
|---|---|
| Biofinity/Air Optix Aqua Combination Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity). | 67 |
| Biofinity/Purevision Combination Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity). | 65 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Baseline Visit | Withdrawal by Subject | 0 | 2 | 0 | 2 |
| Second Intervention (up to 24 Days) | Lost to Follow-up | 4 | 3 | 1 | 3 |
| Second Intervention (up to 24 Days) | Withdrawal by Subject | 2 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Biofinity/Air Optix Aqua Combination | Biofinity/Purevision Combination | Total |
|---|---|---|---|
| Age, Continuous | 53.51 years STANDARD_DEVIATION 6.5 | 52.35 years STANDARD_DEVIATION 5.48 | 52.94 years STANDARD_DEVIATION 6.02 |
| Sex/Gender, Customized Female | 52 participants | 48 participants | 101 participants |
| Sex/Gender, Customized Male | 15 participants | 17 participants | 32 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 138 |
| serious Total, serious adverse events | 0 / 138 |
Outcome results
Primary
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
Time frame: Change over time measured at V1, V3 and V5
Population: Percentage of patients who obtained distance and near binocular visual acuities at least as good as their initial refraction visual acuities.~(Participant Flow: Biofinity Multifocal N=138, 14 missing values; Air Optix Aqua Multifocal N=70, 12 missing values; Purevision Multifocal N=68, 13 missing values)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biofinity Multifocal | Visual Performance - Comparison of Initial Refraction to Multifocal Lenses | 65.3 percentage of participants |
| Air Optix Aqua Multifocal | Visual Performance - Comparison of Initial Refraction to Multifocal Lenses | 48.3 percentage of participants |
| Purevision Multifocal | Visual Performance - Comparison of Initial Refraction to Multifocal Lenses | 49.1 percentage of participants |
Secondary
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
Time frame: Measured at 17-24 days V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Clinical Performance - Lens Wettability | None/Low/Acceptable | 31.1 percentage of investigators |
| Biofinity Multifocal | Clinical Performance - Lens Wettability | Good/Excellent | 68.9 percentage of investigators |
| Air Optix Aqua Multifocal | Clinical Performance - Lens Wettability | None/Low/Acceptable | 53.8 percentage of investigators |
| Air Optix Aqua Multifocal | Clinical Performance - Lens Wettability | Good/Excellent | 46.2 percentage of investigators |
| Purevision Multifocal | Clinical Performance - Lens Wettability | None/Low/Acceptable | 52.4 percentage of investigators |
| Purevision Multifocal | Clinical Performance - Lens Wettability | Good/Excellent | 47.6 percentage of investigators |
Secondary
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)
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 11 missing values; Air Optix Aqua Multifocal N=70, 10 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Comfort of Use - Average Wearing Time | 11.61 hours/day | Standard Deviation 3.26 |
| Air Optix Aqua Multifocal | Comfort of Use - Average Wearing Time | 10.7 hours/day | Standard Deviation 3.04 |
| Purevision Multifocal | Comfort of Use - Average Wearing Time | 11.27 hours/day | Standard Deviation 3.62 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 12 missing values; Air Optix Aqua Multifocal N=70, 9 missing values; Purevision Multifocal N=68, 6 missing values)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Geometric Performance - Lens Centration | Acceptable Shift | 4 Investigators |
| Biofinity Multifocal | Geometric Performance - Lens Centration | Optimal | 122 Investigators |
| Air Optix Aqua Multifocal | Geometric Performance - Lens Centration | Acceptable Shift | 4 Investigators |
| Air Optix Aqua Multifocal | Geometric Performance - Lens Centration | Optimal | 57 Investigators |
| Purevision Multifocal | Geometric Performance - Lens Centration | Acceptable Shift | 8 Investigators |
| Purevision Multifocal | Geometric Performance - Lens Centration | Optimal | 54 Investigators |
Secondary
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
Time frame: Measured at 17-24 days V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Geometric Performance - Lens Mobility | Acceptable Tight Tendency | 13 Investigators |
| Biofinity Multifocal | Geometric Performance - Lens Mobility | Optimal | 116 Investigators |
| Biofinity Multifocal | Geometric Performance - Lens Mobility | Acceptable Flat Tendency | 3 Investigators |
| Air Optix Aqua Multifocal | Geometric Performance - Lens Mobility | Acceptable Tight Tendency | 4 Investigators |
| Air Optix Aqua Multifocal | Geometric Performance - Lens Mobility | Optimal | 58 Investigators |
| Air Optix Aqua Multifocal | Geometric Performance - Lens Mobility | Acceptable Flat Tendency | 3 Investigators |
| Purevision Multifocal | Geometric Performance - Lens Mobility | Optimal | 49 Investigators |
| Purevision Multifocal | Geometric Performance - Lens Mobility | Acceptable Flat Tendency | 1 Investigators |
| Purevision Multifocal | Geometric Performance - Lens Mobility | Acceptable Tight Tendency | 13 Investigators |
Secondary
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.
Time frame: Measured at 17-24 days V3 or V5
Population: (Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 8 missing values; Evaluated at least one lens N=138, 16 missing values.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Lens Preference - Ophthalmologist | Air Optix | 35.5 percentage of investigators |
| Biofinity Multifocal | Lens Preference - Ophthalmologist | Biofinity | 64.5 percentage of investigators |
| Biofinity Multifocal | Lens Preference - Ophthalmologist | Purevision | 0 percentage of investigators |
| Air Optix Aqua Multifocal | Lens Preference - Ophthalmologist | Air Optix | 0 percentage of investigators |
| Air Optix Aqua Multifocal | Lens Preference - Ophthalmologist | Biofinity | 80.0 percentage of investigators |
| Air Optix Aqua Multifocal | Lens Preference - Ophthalmologist | Purevision | 20.0 percentage of investigators |
| Purevision Multifocal | Lens Preference - Ophthalmologist | Biofinity | 72.1 percentage of investigators |
| Purevision Multifocal | Lens Preference - Ophthalmologist | Purevision | 9.8 percentage of investigators |
| Purevision Multifocal | Lens Preference - Ophthalmologist | Air Optix | 18.0 percentage of investigators |
Secondary
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.
Time frame: Measured at V5
Population: (Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 7 missing values; Evaluated at least one lens N=138, 15 missing values.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Lens Preference - Participant | Biofinity | 59.7 percentage of participants |
| Biofinity Multifocal | Lens Preference - Participant | Purevision | 0 percentage of participants |
| Biofinity Multifocal | Lens Preference - Participant | Air Optix | 40.3 percentage of participants |
| Air Optix Aqua Multifocal | Lens Preference - Participant | Air Optix | 0 percentage of participants |
| Air Optix Aqua Multifocal | Lens Preference - Participant | Purevision | 23.0 percentage of participants |
| Air Optix Aqua Multifocal | Lens Preference - Participant | Biofinity | 77.0 percentage of participants |
| Purevision Multifocal | Lens Preference - Participant | Purevision | 11.4 percentage of participants |
| Purevision Multifocal | Lens Preference - Participant | Biofinity | 68.3 percentage of participants |
| Purevision Multifocal | Lens Preference - Participant | Air Optix | 20.3 percentage of participants |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Subjective Rating of Lens Comfort - During Day | 84.95 units on a scale | Standard Deviation 16.63 |
| Air Optix Aqua Multifocal | Subjective Rating of Lens Comfort - During Day | 81.54 units on a scale | Standard Deviation 20.71 |
| Purevision Multifocal | Subjective Rating of Lens Comfort - During Day | 73.41 units on a scale | Standard Deviation 23.4 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Subjective Rating of Lens Comfort - End of Day | 77.98 units on a scale | Standard Deviation 20.66 |
| Air Optix Aqua Multifocal | Subjective Rating of Lens Comfort - End of Day | 73.51 units on a scale | Standard Deviation 24.9 |
| Purevision Multifocal | Subjective Rating of Lens Comfort - End of Day | 61.6 units on a scale | Standard Deviation 27.78 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Subjective Rating of Lens Comfort, Fitting | 86.27 units on a scale | Standard Deviation 17.65 |
| Air Optix Aqua Multifocal | Subjective Rating of Lens Comfort, Fitting | 80.77 units on a scale | Standard Deviation 19.19 |
| Purevision Multifocal | Subjective Rating of Lens Comfort, Fitting | 73.46 units on a scale | Standard Deviation 24.26 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Subjective Rating of Lens Comfort - General Comfort | 85.66 units on a scale | Standard Deviation 15.99 |
| Air Optix Aqua Multifocal | Subjective Rating of Lens Comfort - General Comfort | 81.72 units on a scale | Standard Deviation 21.51 |
| Purevision Multifocal | Subjective Rating of Lens Comfort - General Comfort | 70.75 units on a scale | Standard Deviation 25.4 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance: Distance, High Contrast Vision | 39.76 number of letters read | Standard Deviation 14.05 |
| Air Optix Aqua Multifocal | Visual Performance: Distance, High Contrast Vision | 36.63 number of letters read | Standard Deviation 14.71 |
| Purevision Multifocal | Visual Performance: Distance, High Contrast Vision | 38.75 number of letters read | Standard Deviation 13.75 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance: Distance, Low Contrast Vision | 19.09 number of letters read | Standard Deviation 15.51 |
| Air Optix Aqua Multifocal | Visual Performance: Distance, Low Contrast Vision | 17.77 number of letters read | Standard Deviation 15.43 |
| Purevision Multifocal | Visual Performance: Distance, Low Contrast Vision | 18.77 number of letters read | Standard Deviation 15.24 |
Secondary
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
Time frame: Measure at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 6 missing values; Purevision Multifocal N=68, 6 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Distance Visual Acuity | 10.18 decimal units on a scale | Standard Deviation 1.51 |
| Air Optix Aqua Multifocal | Visual Performance - Distance Visual Acuity | 9.87 decimal units on a scale | Standard Deviation 1.03 |
| Purevision Multifocal | Visual Performance - Distance Visual Acuity | 10.28 decimal units on a scale | Standard Deviation 1.3 |
Secondary
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
Time frame: Measured at 17-24 days V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance: Near, High Contrast Vision | 53.91 number of letters read | Standard Deviation 12.72 |
| Air Optix Aqua Multifocal | Visual Performance: Near, High Contrast Vision | 49.11 number of letters read | Standard Deviation 13.51 |
| Purevision Multifocal | Visual Performance: Near, High Contrast Vision | 52.83 number of letters read | Standard Deviation 12.8 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Near, Low Contrast Vision | 33.82 number of letters read | Standard Deviation 11.74 |
| Air Optix Aqua Multifocal | Visual Performance - Near, Low Contrast Vision | 31.76 number of letters read | Standard Deviation 12.09 |
| Purevision Multifocal | Visual Performance - Near, Low Contrast Vision | 34.64 number of letters read | Standard Deviation 12.07 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 10 missing values; Air Optix Aqua Multifocal N=70, 7 missing values; Purevision Multifocal N=68, 4 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Near Stereoscopic Vision | 7.01 number of occurrances | Standard Deviation 2.38 |
| Air Optix Aqua Multifocal | Visual Performance - Near Stereoscopic Vision | 6.21 number of occurrances | Standard Deviation 2.71 |
| Purevision Multifocal | Visual Performance - Near Stereoscopic Vision | 6.7 number of occurrances | Standard Deviation 2.69 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 8 missing values; Purevision Multifocal N=68, 8 missing values)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Near Visual Acuity | P1.5/P2 | 122 participants |
| Biofinity Multifocal | Visual Performance - Near Visual Acuity | P3 | 12 participants |
| Biofinity Multifocal | Visual Performance - Near Visual Acuity | P4 | 0 participants |
| Biofinity Multifocal | Visual Performance - Near Visual Acuity | P5 | 0 participants |
| Air Optix Aqua Multifocal | Visual Performance - Near Visual Acuity | P5 | 1 participants |
| Air Optix Aqua Multifocal | Visual Performance - Near Visual Acuity | P1.5/P2 | 49 participants |
| Air Optix Aqua Multifocal | Visual Performance - Near Visual Acuity | P4 | 2 participants |
| Air Optix Aqua Multifocal | Visual Performance - Near Visual Acuity | P3 | 10 participants |
| Purevision Multifocal | Visual Performance - Near Visual Acuity | P5 | 0 participants |
| Purevision Multifocal | Visual Performance - Near Visual Acuity | P3 | 7 participants |
| Purevision Multifocal | Visual Performance - Near Visual Acuity | P4 | 2 participants |
| Purevision Multifocal | Visual Performance - Near Visual Acuity | P1.5/P2 | 51 participants |
Secondary
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
Time frame: Measured at 17-24 days V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Quality of Distance Vision | 73.54 units on a scale | Standard Deviation 20.63 |
| Air Optix Aqua Multifocal | Visual Performance - Quality of Distance Vision | 74.18 units on a scale | Standard Deviation 20.75 |
| Purevision Multifocal | Visual Performance - Quality of Distance Vision | 74.33 units on a scale | Standard Deviation 23.15 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 3 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Quality of Intermediate Vision | 81.25 units on a scale | Standard Deviation 19.66 |
| Air Optix Aqua Multifocal | Visual Performance - Quality of Intermediate Vision | 75.67 units on a scale | Standard Deviation 23.56 |
| Purevision Multifocal | Visual Performance - Quality of Intermediate Vision | 76.08 units on a scale | Standard Deviation 21.11 |
Secondary
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
Time frame: Measured at V3 or V5
Population: (Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofinity Multifocal | Visual Performance - Quality of Near Vision | 83.19 units on a scale | Standard Deviation 18.64 |
| Air Optix Aqua Multifocal | Visual Performance - Quality of Near Vision | 70.97 units on a scale | Standard Deviation 26.3 |
| Purevision Multifocal | Visual Performance - Quality of Near Vision | 71.27 units on a scale | Standard Deviation 24.18 |