Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)

Conditions
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Presbyopia

Intervention / Treatment
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* Device: BIOFINITY® MF - AIR OPTIX® AQUA MF
* Device: BIOFINITY® MF - PUREVISION® MF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOFINITY® MF - AIR OPTIX® AQUA MF<br>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) | Device: BIOFINITY® MF - AIR OPTIX® AQUA MF<br>* 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)<br>* Other names: AIR OPTIX® AQUA MULTIFOCAL;Device: BIOFINITY® MF - PUREVISION® MF<br>* 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)<br>* Other names: PUREVISION® MULTIFOCAL;|
| Active Comparator: BIOFINITY® MF - PUREVISION® MF<br>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) | Device: BIOFINITY® MF - AIR OPTIX® AQUA MF<br>* 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)<br>* Other names: AIR OPTIX® AQUA MULTIFOCAL;Device: BIOFINITY® MF - PUREVISION® MF<br>* 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)<br>* Other names: PUREVISION® MULTIFOCAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change over time measured at V1, V3 and V5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 at 17-24 days V3 or V5 |