Trial Outcomes & Findings for Bifocal Lenses In Nearsighted Kids (NCT NCT02255474)
NCT ID: NCT02255474
Last Updated: 2021-03-10
Results Overview
Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
294 participants
Primary outcome timeframe
3 years
Results posted on
2021-03-10
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Biofinity
Soft spherical contact lens
Biofinity: This is a monthly disposable spherical contact lens commercially available from CooperVision
|
Biofinity Multifocal D +1.50 Add
The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power
Biofinity Multifocal D +1.50 add: This is a monthly disposable contact lens commercially available from CooperVision
|
Biofinity Multifocal D +2.50 Add
The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power
Biofinity Multifocal D +2.50 add: This is a monthly disposable contact lens commercially available from CooperVision
|
|---|---|---|---|
|
Overall Study
STARTED
|
98 98
|
98 98
|
98 98
|
|
Overall Study
COMPLETED
|
96 96
|
96 96
|
95 95
|
|
Overall Study
NOT COMPLETED
|
2 2
|
2 2
|
3 3
|
Reasons for withdrawal
| Measure |
Biofinity
Soft spherical contact lens
Biofinity: This is a monthly disposable spherical contact lens commercially available from CooperVision
|
Biofinity Multifocal D +1.50 Add
The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power
Biofinity Multifocal D +1.50 add: This is a monthly disposable contact lens commercially available from CooperVision
|
Biofinity Multifocal D +2.50 Add
The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power
Biofinity Multifocal D +2.50 add: This is a monthly disposable contact lens commercially available from CooperVision
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
Bifocal Lenses In Nearsighted Kids
Baseline characteristics by cohort
| Measure |
Biofinity
n=98 Participants
Single vision soft contact lens
|
Biofinity +1.50 D Add
n=98 Participants
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=98 Participants
High add soft bifocal contact lens (+2.50 Diopter add)
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
98 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
294 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
10.3 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
10.3 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
10.36 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
10.3 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Age, Customized
Age · 7 to 9 years
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Age, Customized
Age · 10 to 11 years
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
98 participants
n=7 Participants
|
98 participants
n=5 Participants
|
294 participants
n=4 Participants
|
|
Site
Columbus, OH
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Site
Houston, TX
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Spherical equivalent
|
-2.46 Diopters
STANDARD_DEVIATION 0.97 • n=5 Participants
|
-2.43 Diopters
STANDARD_DEVIATION 1.11 • n=7 Participants
|
-2.28 Diopters
STANDARD_DEVIATION 0.90 • n=5 Participants
|
-2.39 Diopters
STANDARD_DEVIATION 1.00 • n=4 Participants
|
|
Axial length
|
24.45 mm
STANDARD_DEVIATION 0.83 • n=5 Participants
|
24.57 mm
STANDARD_DEVIATION 0.85 • n=7 Participants
|
24.43 mm
STANDARD_DEVIATION 0.74 • n=5 Participants
|
24.48 mm
STANDARD_DEVIATION 0.81 • n=4 Participants
|
|
Peripheral axial length
20 degree inferior
|
24.27 mm
STANDARD_DEVIATION 0.83 • n=5 Participants
|
24.37 mm
STANDARD_DEVIATION 0.85 • n=7 Participants
|
24.24 mm
STANDARD_DEVIATION 0.74 • n=5 Participants
|
24.29 mm
STANDARD_DEVIATION 0.81 • n=4 Participants
|
|
Peripheral axial length
20 degree nasal
|
24.16 mm
STANDARD_DEVIATION 0.85 • n=5 Participants
|
24.31 mm
STANDARD_DEVIATION 0.95 • n=7 Participants
|
24.15 mm
STANDARD_DEVIATION 0.86 • n=5 Participants
|
24.20 mm
STANDARD_DEVIATION 0.88 • n=4 Participants
|
|
Peripheral axial length
20 degree superior
|
24.38 mm
STANDARD_DEVIATION 0.84 • n=5 Participants
|
24.45 mm
STANDARD_DEVIATION 0.85 • n=7 Participants
|
24.36 mm
STANDARD_DEVIATION 0.79 • n=5 Participants
|
24.40 mm
STANDARD_DEVIATION 0.82 • n=4 Participants
|
|
Peripheral axial length
20 degree temporal
|
24.07 mm
STANDARD_DEVIATION 0.85 • n=5 Participants
|
24.20 mm
STANDARD_DEVIATION 0.84 • n=7 Participants
|
24.06 mm
STANDARD_DEVIATION 0.74 • n=5 Participants
|
24.11 mm
STANDARD_DEVIATION 0.81 • n=4 Participants
|
|
Peripheral axial length
30 degree inferior
|
24.03 mm
STANDARD_DEVIATION 0.81 • n=5 Participants
|
24.13 mm
STANDARD_DEVIATION 0.82 • n=7 Participants
|
24.01 mm
STANDARD_DEVIATION 0.72 • n=5 Participants
|
24.06 mm
STANDARD_DEVIATION 0.78 • n=4 Participants
|
|
Peripheral axial length
30 degree nasal
|
24.08 mm
STANDARD_DEVIATION 0.85 • n=5 Participants
|
24.22 mm
STANDARD_DEVIATION 0.87 • n=7 Participants
|
24.07 mm
STANDARD_DEVIATION 0.79 • n=5 Participants
|
24.13 mm
STANDARD_DEVIATION 0.84 • n=4 Participants
|
|
Peripheral axial length
30 degree superior
|
24.20 mm
STANDARD_DEVIATION 0.86 • n=5 Participants
|
24.25 mm
STANDARD_DEVIATION 0.86 • n=7 Participants
|
24.19 mm
STANDARD_DEVIATION 0.80 • n=5 Participants
|
24.21 mm
STANDARD_DEVIATION 0.84 • n=4 Participants
|
|
Peripheral axial length
30 degree temporal
|
23.69 mm
STANDARD_DEVIATION 0.820 • n=5 Participants
|
23.82 mm
STANDARD_DEVIATION 0.80 • n=7 Participants
|
23.69 mm
STANDARD_DEVIATION 0.73 • n=5 Participants
|
23.73 mm
STANDARD_DEVIATION 0.79 • n=4 Participants
|
|
Peripheral defocus
40 degree nasal
|
2.17 Diopters
STANDARD_DEVIATION 1.17 • n=5 Participants
|
1.07 Diopters
STANDARD_DEVIATION 1.30 • n=7 Participants
|
0.44 Diopters
STANDARD_DEVIATION 1.23 • n=5 Participants
|
1.23 Diopters
STANDARD_DEVIATION 1.42 • n=4 Participants
|
|
Peripheral defocus
30 degree nasal
|
1.06 Diopters
STANDARD_DEVIATION 0.84 • n=5 Participants
|
0.16 Diopters
STANDARD_DEVIATION 1.02 • n=7 Participants
|
-0.37 Diopters
STANDARD_DEVIATION 0.95 • n=5 Participants
|
0.28 Diopters
STANDARD_DEVIATION 1.10 • n=4 Participants
|
|
Peripheral defocus
20 degree nasal
|
0.54 Diopters
STANDARD_DEVIATION 0.81 • n=5 Participants
|
-0.10 Diopters
STANDARD_DEVIATION 0.77 • n=7 Participants
|
-0.37 Diopters
STANDARD_DEVIATION 0.75 • n=5 Participants
|
0.02 Diopters
STANDARD_DEVIATION 0.86 • n=4 Participants
|
|
Peripheral defocus
20 degree temporal
|
0.56 Diopters
STANDARD_DEVIATION 0.75 • n=5 Participants
|
-0.27 Diopters
STANDARD_DEVIATION 0.79 • n=7 Participants
|
-0.86 Diopters
STANDARD_DEVIATION 0.74 • n=5 Participants
|
-0.19 Diopters
STANDARD_DEVIATION 0.96 • n=4 Participants
|
|
Peripheral defocus
30 degree temporal
|
1.29 Diopters
STANDARD_DEVIATION 1.06 • n=5 Participants
|
0.27 Diopters
STANDARD_DEVIATION 1.07 • n=7 Participants
|
-0.35 Diopters
STANDARD_DEVIATION 1.21 • n=5 Participants
|
0.40 Diopters
STANDARD_DEVIATION 1.30 • n=4 Participants
|
|
Peripheral defocus
40 degree temporal
|
1.92 Diopters
STANDARD_DEVIATION 1.64 • n=5 Participants
|
1.33 Diopters
STANDARD_DEVIATION 1.71 • n=7 Participants
|
0.87 Diopters
STANDARD_DEVIATION 1.64 • n=5 Participants
|
1.37 Diopters
STANDARD_DEVIATION 1.72 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 yearsRefractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
Outcome measures
| Measure |
Biofinity
n=97 Participants
Spherical soft contact lens
|
Biofinity +1.50 D Add
n=98 Participants
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=97 Participants
High add soft bifocal contact lens (+2.50 Diopter add)
|
|---|---|---|---|
|
Refractive Error Progression
|
-3.46 Diopters
Standard Deviation 1.20
|
-3.32 Diopters
Standard Deviation 1.48
|
-2.84 Diopters
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Analysis of peripheral eye length changes with treatment
The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).
Outcome measures
| Measure |
Biofinity
n=97 Participants
Spherical soft contact lens
|
Biofinity +1.50 D Add
n=98 Participants
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=97 Participants
High add soft bifocal contact lens (+2.50 Diopter add)
|
|---|---|---|---|
|
Ocular Shape Change and Eye Growth
20 degree inferior
|
24.92 mm
Standard Deviation 0.85
|
24.94 mm
Standard Deviation 0.97
|
24.64 mm
Standard Deviation 0.79
|
|
Ocular Shape Change and Eye Growth
30 degree nasal
|
24.70 mm
Standard Deviation 0.84
|
24.79 mm
Standard Deviation 1.01
|
24.51 mm
Standard Deviation 0.87
|
|
Ocular Shape Change and Eye Growth
30 degree superior
|
24.76 mm
Standard Deviation 0.92
|
247.77 mm
Standard Deviation 0.95
|
24.58 mm
Standard Deviation 0.86
|
|
Ocular Shape Change and Eye Growth
30 degree temporal
|
24.30 mm
Standard Deviation 0.82
|
24.29 mm
Standard Deviation 0.91
|
24.04 mm
Standard Deviation 0.81
|
|
Ocular Shape Change and Eye Growth
20 degree nasal
|
24.86 mm
Standard Deviation 0.87
|
24.90 mm
Standard Deviation 1.09
|
24.60 mm
Standard Deviation 0.93
|
|
Ocular Shape Change and Eye Growth
20 degree superior
|
24.98 mm
Standard Deviation 0.89
|
24.98 mm
Standard Deviation 0.97
|
24.74 mm
Standard Deviation 0.84
|
|
Ocular Shape Change and Eye Growth
20 degree temporal
|
24.98 mm
Standard Deviation 0.89
|
24.98 mm
Standard Deviation 0.97
|
24.71 mm
Standard Deviation 0.84
|
|
Ocular Shape Change and Eye Growth
30 degree inferior
|
24.64 mm
Standard Deviation 0.83
|
24.68 mm
Standard Deviation 0.94
|
24.45 mm
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: outcome is three-year change in refractive error as a function of baseline peripheral defocus
Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).
Outcome measures
| Measure |
Biofinity
n=97 Participants
Spherical soft contact lens
|
Biofinity +1.50 D Add
n=98 Participants
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=97 Participants
High add soft bifocal contact lens (+2.50 Diopter add)
|
|---|---|---|---|
|
Association of Peripheral Defocus to Myopic Progression
|
-1.01 Diopters
Standard Deviation 0.66
|
-0.85 Diopters
Standard Deviation 0.82
|
-0.56 Diopters
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 3 yearsAxial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
Outcome measures
| Measure |
Biofinity
n=97 Participants
Spherical soft contact lens
|
Biofinity +1.50 D Add
n=98 Participants
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=97 Participants
High add soft bifocal contact lens (+2.50 Diopter add)
|
|---|---|---|---|
|
Axial Length Progression
|
25.08 mm
Standard Deviation 0.85
|
25.12 mm
Standard Deviation 0.97
|
24.81 mm
Standard Deviation 0.83
|
Adverse Events
Biofinity
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Biofinity +1.50 D Add
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Biofinity +2.50 D Add
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biofinity
n=97 participants at risk；n=98 participants at risk
Spherical soft contact lens
|
Biofinity +1.50 D Add
n=98 participants at risk
Medium add soft bifocal contact lens (+1.50 Diopter add)
|
Biofinity +2.50 D Add
n=97 participants at risk；n=98 participants at risk
High add soft bifocal contact lens (+2.50 Diopter add)
|
|---|---|---|---|
|
Eye disorders
Visual symptoms, no obvious cause
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Immune system disorders
Allergy, non-ocular
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
General disorders
Trauma, non-ocular
|
19.6%
19/97 • Number of events 21 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
12.2%
12/98 • Number of events 13 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
7.2%
7/97 • Number of events 9 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
General disorders
Headaches
|
6.2%
6/97 • Number of events 7 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/98 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
6.2%
6/97 • Number of events 7 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
General disorders
Concussion
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
4.1%
4/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
General disorders
Systemic disease
|
8.2%
8/97 • Number of events 8 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
9.2%
9/98 • Number of events 9 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
10.3%
10/97 • Number of events 12 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Psychiatric disorders
Mental health issues
|
4.1%
4/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
General disorders
Can't categorize
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
SEAL
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
CLARE
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Corneal epithelial defect
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Infiltrative keratitis
|
5.2%
5/97 • Number of events 6 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
4.1%
4/98 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Probable microbial keratitis
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Sterile Corneal Ulcer
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Toxic exposure
|
4.1%
4/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/98 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Giant papillary conjunctivitis
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.1%
5/98 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Ocular allergies
|
9.3%
9/97 • Number of events 9 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
12.2%
12/98 • Number of events 12 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
22.7%
22/97 • Number of events 25 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Blepharitis
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Hordeolum/chalazion
|
9.3%
9/97 • Number of events 10 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/98 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
7.2%
7/97 • Number of events 10 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Eyelash issue
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Ptosis
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Corneal scar, new
|
3.1%
3/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.1%
5/98 • Number of events 6 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
4.1%
4/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Solution induced corneal staining
|
28.9%
28/97 • Number of events 28 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
35.7%
35/98 • Number of events 35 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
28.9%
28/97 • Number of events 28 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Poor contact lens fit
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Foreign body
|
2.1%
2/97 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Dry eye
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/98 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Contact lens solution issue
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Conjunctivitis, any type
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.1%
5/98 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Subconjunctival hemorrhage
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Retinal issue
|
4.1%
4/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
4.1%
4/97 • Number of events 4 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Optic nerve issue
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Uveitis
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Trauma, ocular
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/98 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Binocular vision/accommodation issue
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
5.2%
5/97 • Number of events 5 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Color vision defect
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
1.0%
1/98 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Transient visual disturbance
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
0.00%
0/97 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
|
Eye disorders
Unspecified contact lens issue
|
1.0%
1/97 • Number of events 1 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
2.0%
2/98 • Number of events 2 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
3.1%
3/97 • Number of events 3 • Three years
Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place