Trial Outcomes & Findings for Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal (NCT NCT01591499)
NCT ID: NCT01591499
Last Updated: 2020-08-11
Results Overview
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
COMPLETED
NA
142 participants
Change over time measured at V1, V3 and V5
2020-08-11
Participant Flow
Multi-center study conducted by 15 freelance opthalmologiests to enroll 180 patients.
Participant milestones
| Measure |
Biofinity Then Air Optix
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.
|
Air Optix Then Biofinity
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.
|
Biofinity Then Purevision
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.
|
Purevision Then Biofinity
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.
|
|---|---|---|---|---|
|
Baseline Visit
STARTED
|
33
|
39
|
31
|
39
|
|
Baseline Visit
COMPLETED
|
33
|
37
|
31
|
37
|
|
Baseline Visit
NOT COMPLETED
|
0
|
2
|
0
|
2
|
|
First Intervention (up to 24 Days)
STARTED
|
33
|
37
|
31
|
37
|
|
First Intervention (up to 24 Days)
COMPLETED
|
33
|
37
|
31
|
37
|
|
First Intervention (up to 24 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (up to 24 Days)
STARTED
|
33
|
37
|
31
|
37
|
|
Second Intervention (up to 24 Days)
COMPLETED
|
27
|
34
|
28
|
34
|
|
Second Intervention (up to 24 Days)
NOT COMPLETED
|
6
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Biofinity Then Air Optix
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.
|
Air Optix Then Biofinity
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.
|
Biofinity Then Purevision
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.
|
Purevision Then Biofinity
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.
|
|---|---|---|---|---|
|
Baseline Visit
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
|
Second Intervention (up to 24 Days)
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
|
Second Intervention (up to 24 Days)
Lost to Follow-up
|
4
|
3
|
1
|
3
|
Baseline Characteristics
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
Baseline characteristics by cohort
| Measure |
Biofinity/Air Optix Aqua Combination
n=67 Participants
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).
|
Biofinity/Purevision Combination
n=65 Participants
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
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.51 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
52.35 years
STANDARD_DEVIATION 5.48 • n=7 Participants
|
52.94 years
STANDARD_DEVIATION 6.02 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
52 participants
n=5 Participants
|
48 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change over time measured at V1, V3 and V5Population: 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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=55 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=58 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=124 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
|
49.1 percentage of participants
|
48.3 percentage of participants
|
65.3 percentage of participants
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=60 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=62 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=134 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Near Visual Acuity
P1.5/P2
|
51 participants
|
49 participants
|
122 participants
|
|
Visual Performance - Near Visual Acuity
P3
|
7 participants
|
10 participants
|
12 participants
|
|
Visual Performance - Near Visual Acuity
P4
|
2 participants
|
2 participants
|
0 participants
|
|
Visual Performance - Near Visual Acuity
P5
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measure at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=64 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=133 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Distance Visual Acuity
|
10.28 decimal units on a scale
Standard Deviation 1.3
|
9.87 decimal units on a scale
Standard Deviation 1.03
|
10.18 decimal units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=66 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=67 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=135 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Quality of Near Vision
|
71.27 units on a scale
Standard Deviation 24.18
|
70.97 units on a scale
Standard Deviation 26.3
|
83.19 units on a scale
Standard Deviation 18.64
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=65 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=67 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=135 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Quality of Intermediate Vision
|
76.08 units on a scale
Standard Deviation 21.11
|
75.67 units on a scale
Standard Deviation 23.56
|
81.25 units on a scale
Standard Deviation 19.66
|
SECONDARY outcome
Timeframe: Measured at 17-24 days V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=66 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=67 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=134 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Quality of Distance Vision
|
74.33 units on a scale
Standard Deviation 23.15
|
74.18 units on a scale
Standard Deviation 20.75
|
73.54 units on a scale
Standard Deviation 20.63
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=66 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=134 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Near, Low Contrast Vision
|
34.64 number of letters read
Standard Deviation 12.07
|
31.76 number of letters read
Standard Deviation 12.09
|
33.82 number of letters read
Standard Deviation 11.74
|
SECONDARY outcome
Timeframe: Measured at 17-24 days V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=66 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=134 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance: Near, High Contrast Vision
|
52.83 number of letters read
Standard Deviation 12.8
|
49.11 number of letters read
Standard Deviation 13.51
|
53.91 number of letters read
Standard Deviation 12.72
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=66 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=134 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance: Distance, Low Contrast Vision
|
18.77 number of letters read
Standard Deviation 15.24
|
17.77 number of letters read
Standard Deviation 15.43
|
19.09 number of letters read
Standard Deviation 15.51
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=133 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance: Distance, High Contrast Vision
|
38.75 number of letters read
Standard Deviation 13.75
|
36.63 number of letters read
Standard Deviation 14.71
|
39.76 number of letters read
Standard Deviation 14.05
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=63 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=128 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Visual Performance - Near Stereoscopic Vision
|
6.7 number of occurrances
Standard Deviation 2.69
|
6.21 number of occurrances
Standard Deviation 2.71
|
7.01 number of occurrances
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=63 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=131 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Subjective Rating of Lens Comfort, Fitting
|
73.46 units on a scale
Standard Deviation 24.26
|
80.77 units on a scale
Standard Deviation 19.19
|
86.27 units on a scale
Standard Deviation 17.65
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=131 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Subjective Rating of Lens Comfort - During Day
|
73.41 units on a scale
Standard Deviation 23.4
|
81.54 units on a scale
Standard Deviation 20.71
|
84.95 units on a scale
Standard Deviation 16.63
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=63 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=131 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Subjective Rating of Lens Comfort - End of Day
|
61.6 units on a scale
Standard Deviation 27.78
|
73.51 units on a scale
Standard Deviation 24.9
|
77.98 units on a scale
Standard Deviation 20.66
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=64 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=131 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Subjective Rating of Lens Comfort - General Comfort
|
70.75 units on a scale
Standard Deviation 25.4
|
81.72 units on a scale
Standard Deviation 21.51
|
85.66 units on a scale
Standard Deviation 15.99
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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)
Outcome measures
| Measure |
Purevision Multifocal
n=62 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=60 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=127 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Comfort of Use - Average Wearing Time
|
11.27 hours/day
Standard Deviation 3.62
|
10.7 hours/day
Standard Deviation 3.04
|
11.61 hours/day
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Measured at V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=62 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=61 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=126 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Geometric Performance - Lens Centration
Optimal
|
54 Investigators
|
57 Investigators
|
122 Investigators
|
|
Geometric Performance - Lens Centration
Acceptable Shift
|
8 Investigators
|
4 Investigators
|
4 Investigators
|
SECONDARY outcome
Timeframe: Measured at 17-24 days V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=63 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=132 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Geometric Performance - Lens Mobility
Optimal
|
49 Investigators
|
58 Investigators
|
116 Investigators
|
|
Geometric Performance - Lens Mobility
Acceptable Tight Tendency
|
13 Investigators
|
4 Investigators
|
13 Investigators
|
|
Geometric Performance - Lens Mobility
Acceptable Flat Tendency
|
1 Investigators
|
3 Investigators
|
3 Investigators
|
SECONDARY outcome
Timeframe: Measured at 17-24 days V3 or V5Population: (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)
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
Outcome measures
| Measure |
Purevision Multifocal
n=63 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=65 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=132 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Clinical Performance - Lens Wettability
None/Low/Acceptable
|
52.4 percentage of investigators
|
53.8 percentage of investigators
|
31.1 percentage of investigators
|
|
Clinical Performance - Lens Wettability
Good/Excellent
|
47.6 percentage of investigators
|
46.2 percentage of investigators
|
68.9 percentage of investigators
|
SECONDARY outcome
Timeframe: Measured at V5Population: (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.)
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.
Outcome measures
| Measure |
Purevision Multifocal
n=123 Participants
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=61 Participants
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=62 Participants
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Lens Preference - Participant
Biofinity
|
68.3 percentage of participants
|
77.0 percentage of participants
|
59.7 percentage of participants
|
|
Lens Preference - Participant
Air Optix
|
20.3 percentage of participants
|
0 percentage of participants
|
40.3 percentage of participants
|
|
Lens Preference - Participant
Purevision
|
11.4 percentage of participants
|
23.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Measured at 17-24 days V3 or V5Population: (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.)
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.
Outcome measures
| Measure |
Purevision Multifocal
n=122 lens Type
Geometric performance by lens (Purevision Multifocal)
|
Air Optix Aqua Multifocal
n=60 lens Type
Visual performance by lens (Air Optix Aqua Multifocal)
|
Biofinity Multifocal
n=62 lens Type
Visual performance by lens (Biofinity Multifocal)
|
|---|---|---|---|
|
Lens Preference - Ophthalmologist
Biofinity
|
72.1 percentage of investigators
|
80.0 percentage of investigators
|
64.5 percentage of investigators
|
|
Lens Preference - Ophthalmologist
Air Optix
|
18.0 percentage of investigators
|
0 percentage of investigators
|
35.5 percentage of investigators
|
|
Lens Preference - Ophthalmologist
Purevision
|
9.8 percentage of investigators
|
20.0 percentage of investigators
|
0 percentage of investigators
|
Adverse Events
Overall Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Caroline Bonneville and Sandrine Cheneau, Study Managers
CooperVision
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER