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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01591499
• Collaborator: (none)
• Enrollment: 142
• Arms: 2
• Duration (Months): 12

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: BIOFINITY® MF - AIR OPTIX® AQUA MF; Device: BIOFINITY® MF - PUREVISION® MF	N/A

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

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIOFINITY® 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)	Device: BIOFINITY® 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); Other Names: BIOFINITY® MULTIFOCAL AIR OPTIX® AQUA MULTIFOCAL ; Device: BIOFINITY® 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); Other Names: BIOFINITY® MULTIFOCAL PUREVISION® MULTIFOCAL
Active Comparator: BIOFINITY® 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)	Device: BIOFINITY® 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); Other Names: BIOFINITY® MULTIFOCAL AIR OPTIX® AQUA MULTIFOCAL ; Device: BIOFINITY® 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); Other Names: BIOFINITY® MULTIFOCAL PUREVISION® MULTIFOCAL

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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)

16. 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

17. 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

18. 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

19. 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.

20. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Study Director: Sandrine Cheneau, Coopervision, Inc.
• Study Director: Caroline Bonneville, Coopervision, Inc.
• Principal Investigator: Catherine Peyre, Catherine Peyre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01591499
• Other Study ID Numbers: 2011-A00886-35
• First Posted: May 4, 2012
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	Multi-center study conducted by 15 freelance opthalmologiests to enroll 180 patients.

Arm/Group Title	Biofinity Then Air Optix	Air Optix Then Biofinity	Biofinity Then Purevision	Purevision Then Biofinity
Arm/Group Description	Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5). First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days.	Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5). First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days.	Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5). First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days.	Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5). First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days.
Period Title: Baseline Visit
STARTED	33	39	31	39
COMPLETED	33	37	31	37
NOT COMPLETED	0	2	0	2
Period Title: Baseline Visit
STARTED	33	37	31	37
COMPLETED	33	37	31	37
NOT COMPLETED	0	0	0	0
Period Title: Baseline Visit
STARTED	33	37	31	37
COMPLETED	27	34	28	34
NOT COMPLETED	6	3	3	3

Baseline Characteristics

Arm/Group Title	Biofinity/Air Optix Aqua Combination	Biofinity/Purevision Combination	Total
Arm/Group Description	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).	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).	Total of all reporting groups
Overall Participants	67	65	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.51 (6.5)	52.35 (5.48)	52.94 (6.02)
Sex/Gender, Customized (participants) [Number]
Female	52 77.6%	48 73.8%	101 76.5%
Male	15 22.4%	17 26.2%	32 24.2%

Outcome Measures

1. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	134	62	60
P1.5/P2	122 182.1%	49 75.4%	51 38.6%
P3	12 17.9%	10 15.4%	7 5.3%
P4	0 0%	2 3.1%	2 1.5%
P5	0 0%	1 1.5%	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal)	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	124	58	55
Number [percentage of participants]	65.3 97.5%	48.3 74.3%	49.1 37.2%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	133	64	64
Mean (Standard Deviation) [decimal units on a scale]	10.18 (1.51)	9.87 (1.03)	10.28 (1.3)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	135	67	66
Mean (Standard Deviation) [units on a scale]	83.19 (18.64)	70.97 (26.3)	71.27 (24.18)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	135	67	65
Mean (Standard Deviation) [units on a scale]	81.25 (19.66)	75.67 (23.56)	76.08 (21.11)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	134	67	66
Mean (Standard Deviation) [units on a scale]	73.54 (20.63)	74.18 (20.75)	74.33 (23.15)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	134	66	64
Mean (Standard Deviation) [number of letters read]	33.82 (11.74)	31.76 (12.09)	34.64 (12.07)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	134	66	64
Mean (Standard Deviation) [number of letters read]	53.91 (12.72)	49.11 (13.51)	52.83 (12.8)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	134	66	64
Mean (Standard Deviation) [number of letters read]	19.09 (15.51)	17.77 (15.43)	18.77 (15.24)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	133	65	64
Mean (Standard Deviation) [number of letters read]	39.76 (14.05)	36.63 (14.71)	38.75 (13.75)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Visual performance by lens (Biofinity Multifocal) tested at V3 or V5	Visual performance by lens (Air Optix Aqua Multifocal)	Visual performance by lens (Purevision Multifocal)
Measure Participants	128	63	64
Mean (Standard Deviation) [number of occurrances]	7.01 (2.38)	6.21 (2.71)	6.7 (2.69)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5	Comfort performance by lens (Air Optix Aqua Multifocal)	Comfort performance by lens (Purevision Multifocal)
Measure Participants	131	65	63
Mean (Standard Deviation) [units on a scale]	86.27 (17.65)	80.77 (19.19)	73.46 (24.26)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Performance by lens (Biofinity Multifocal) tested at V3 or V5	Performance by lens (Air Optix Aqua Multifocal)	Performance by lens (Purevision Multifocal)
Measure Participants	131	65	64
Mean (Standard Deviation) [units on a scale]	84.95 (16.63)	81.54 (20.71)	73.41 (23.4)

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Performance by lens (Biofinity Multifocal) tested at V3 or V5	Performance by lens (Air Optix Aqua Multifocal)	Performance by lens (Purevision Multifocal)
Measure Participants	131	65	63
Mean (Standard Deviation) [units on a scale]	77.98 (20.66)	73.51 (24.9)	61.6 (27.78)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Performance by lens (Biofinity Multifocal) tested at V3 or V5	Performance by lens (Air Optix Aqua Multifocal)	Performance by lens (Purevision Multifocal)
Measure Participants	131	65	64
Mean (Standard Deviation) [units on a scale]	85.66 (15.99)	81.72 (21.51)	70.75 (25.4)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Performance by lens (Biofinity Multifocal) tested at V3 or V5	Performance by lens (Air Optix Aqua Multifocal)	Performance by lens (Purevision Multifocal)
Measure Participants	127	60	62
Mean (Standard Deviation) [hours/day]	11.61 (3.26)	10.7 (3.04)	11.27 (3.62)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5	Geometric performance by lens (Air Optix Aqua Multifocal)	Geometric performance by lens (Purevision Multifocal)
Measure Participants	126	61	62
Optimal	122	57	54
Acceptable Shift	4	4	8

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5	Geometric performance by lens (Air Optix Aqua Multifocal)	Geometric performance by lens (Purevision Multifocal)
Measure Participants	132	65	63
Optimal	116	58	49
Acceptable Tight Tendency	13	4	13
Acceptable Flat Tendency	3	3	1

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity Multifocal	Air Optix Aqua Multifocal	Purevision Multifocal
Arm/Group Description	Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5	Clinical performance by lens (Air Optix Aqua Multifocal)	Clinical performance by lens (Purevision Multifocal)
Measure Participants	132	65	63
None/Low/Acceptable	31.1	53.8	52.4
Good/Excellent	68.9	46.2	47.6

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity/Air Optix Combination	Biofinity/Purevision Combination	Evaluated At Least One Lens
Arm/Group Description	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) (Air Optix crossover to Biofinity)	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) (Purevision crossover to Biofinity	Population of patients having evaluated at least one lens pair.
Measure Participants	62	61	123
Biofinity	59.7 89.1%	77.0 118.5%	68.3 51.7%
Air Optix	40.3 60.1%	0 0%	20.3 15.4%
Purevision	0 0%	23.0 35.4%	11.4 8.6%

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(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/Group Title	Biofinity/Air Optix Combination	Biofinity/Purevision Combination	Evaluated At Least One Lens
Arm/Group Description	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) (Air Optix crossover to Biofinity)	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) (Purevision crossover to Biofinity	Population of patients having evaluated at least one lens pair
Measure Participants	62	60	122
Measure lens Type	62	60	122
Biofinity	64.5	80.0	72.1
Air Optix	35.5	0	18.0
Purevision	0	20.0	9.8

Adverse Events

Time Frame	From dispense up to 24 days for both study lenses
Arm/Group Title	Overall Study Population
Arm/Group Description	Population of patients having evaluated at least one lens
All Cause Mortality
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	0/138 (0%)
Other (Not Including Serious) Adverse Events
	Overall Study Population
	Affected / at Risk (%)	# Events
Total	0/138 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All the information collected during this study will be considered to be confidential until the analysis has been finalised by the study Sponsor. All the data collected during this study will remain the property of the study Sponsor and may not be communicated to third parties under any circumstances without the Sponsor's express, written consent. The results may not be published or passed on (orally or in writing) without the prior consent of the study sponsor.