Trial Outcomes & Findings for Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear (NCT NCT02555722)
NCT ID: NCT02555722
Last Updated: 2019-09-25
Results Overview
Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Results posted on
2019-09-25
Participant Flow
Subjects were randomized to the study lenses based on a 2 to 1 ratio within each investigational site and across the entire study using randomization tables.
Two (2) subjects were ineligible and were not randomized and exited the study. This left 90 subjects randomized into the test and control products.
Participant milestones
| Measure |
Fanfilcon A (Test)
Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens
|
Enfilcon A (Control)
Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens
|
|---|---|---|
|
Lens Dispensed
STARTED
|
60
|
30
|
|
Lens Dispensed
COMPLETED
|
60
|
30
|
|
Lens Dispensed
NOT COMPLETED
|
0
|
0
|
|
Week 1
STARTED
|
60
|
30
|
|
Week 1
COMPLETED
|
60
|
30
|
|
Week 1
NOT COMPLETED
|
0
|
0
|
|
Week 2
STARTED
|
60
|
30
|
|
Week 2
COMPLETED
|
59
|
29
|
|
Week 2
NOT COMPLETED
|
1
|
1
|
|
Month 1
STARTED
|
59
|
29
|
|
Month 1
COMPLETED
|
58
|
29
|
|
Month 1
NOT COMPLETED
|
1
|
0
|
|
Month 2
STARTED
|
58
|
29
|
|
Month 2
COMPLETED
|
54
|
29
|
|
Month 2
NOT COMPLETED
|
4
|
0
|
|
Month 3
STARTED
|
54
|
29
|
|
Month 3
COMPLETED
|
54
|
29
|
|
Month 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fanfilcon A (Test)
Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens
|
Enfilcon A (Control)
Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens
|
|---|---|---|
|
Week 2
Adverse Event
|
0
|
1
|
|
Week 2
Withdrawal by Subject
|
1
|
0
|
|
Month 1
Lens Discomfort
|
1
|
0
|
|
Month 2
Withdrawal by Subject
|
3
|
0
|
|
Month 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
Baseline characteristics by cohort
| Measure |
Fanfilcon A (Test)
n=60 Participants
Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens
|
Enfilcon A (Control)
n=30 Participants
Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.72 years
STANDARD_DEVIATION 10.320 • n=5 Participants
|
33.67 years
STANDARD_DEVIATION 10.162 • n=7 Participants
|
34.37 years
STANDARD_DEVIATION 10.223 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Epithelial Edema - Fanfilcon A Lens (Test)
Trace
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Fanfilcon A Lens (Test)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Fanfilcon A Lens (Test)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Fanfilcon A Lens (Test)
None
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
99.1 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Epithelial Edema - Fanfilcon A Lens (Test)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Epithelial Edema - Enfilcon A Lens (Control)
None
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Epithelial Edema - Enfilcon A Lens (Control)
Trace
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Enfilcon A Lens (Control)
MIld
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Enfilcon A Lens (Control)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Epithelial Edema - Enfilcon A Lens (Control)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected during at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Stromal Edema - Fanfilcon A Lens (Test)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Fanfilcon A Lens (Test)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Fanfilcon A Lens (Test)
None
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
99.1 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Stromal Edema - Fanfilcon A Lens (Test)
Trace
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Fanfilcon A Lens (Test)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Stromal Edema - Enfilcon A Lens (Control)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Enfilcon A Lens (Control)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Enfilcon A Lens (Control)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Stromal Edema - Enfilcon A Lens (Control)
None
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Stromal Edema - Enfilcon A Lens (Control)
Trace
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Infiltrates - Fanfilcon A Lens (Test)
Absent
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Infiltrates - Fanfilcon A Lens (Test)
Present
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Infiltrates - Enfilcon A Lens (Control)
Present
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Infiltrates - Enfilcon A Lens (Control)
Absent
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Vascularization - Fanfilcon A Lens (Test)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Fanfilcon A Lens (Test)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Fanfilcon A Lens (Test)
None
|
90.7 percentage of eyes
|
92.6 percentage of eyes
|
92.5 percentage of eyes
|
92.6 percentage of eyes
|
94.4 percentage of eyes
|
91.7 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Vascularization - Fanfilcon A Lens (Test)
Trace
|
9.3 percentage of eyes
|
7.4 percentage of eyes
|
7.5 percentage of eyes
|
7.4 percentage of eyes
|
5.6 percentage of eyes
|
8.3 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Fanfilcon A Lens (Test)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Vascularization - Enfilcon A Lens (Control)
Trace
|
13.8 percentage of eyes
|
7.7 percentage of eyes
|
6.9 percentage of eyes
|
6.9 percentage of eyes
|
3.6 percentage of eyes
|
3.4 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Enfilcon A Lens (Control)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Enfilcon A Lens (Control)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Vascularization - Enfilcon A Lens (Control)
None
|
86.2 percentage of eyes
|
92.3 percentage of eyes
|
93.1 percentage of eyes
|
93.1 percentage of eyes
|
96.4 percentage of eyes
|
96.6 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Vascularization - Enfilcon A Lens (Control)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3
Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Staining - Fanfilcon A Lens (Test)
Superior - None
|
96.3 percentage of eyes
|
92.6 percentage of eyes
|
93.4 percentage of eyes
|
93.5 percentage of eyes
|
97.2 percentage of eyes
|
96.3 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Superior - Trace
|
3.7 percentage of eyes
|
7.4 percentage of eyes
|
2.8 percentage of eyes
|
6.5 percentage of eyes
|
2.8 percentage of eyes
|
2.8 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Superior - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
3.8 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Superior - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Superior - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Temporal - None
|
93.5 percentage of eyes
|
97.2 percentage of eyes
|
95.3 percentage of eyes
|
96.3 percentage of eyes
|
92.6 percentage of eyes
|
90.7 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Temporal - Trace
|
6.5 percentage of eyes
|
2.8 percentage of eyes
|
3.8 percentage of eyes
|
2.8 percentage of eyes
|
5.6 percentage of eyes
|
8.3 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Temporal - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.9 percentage of eyes
|
1.9 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Temporal - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Temporal - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Central - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.9 percentage of eyes
|
1.9 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Central - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Nasal - None
|
90.7 percentage of eyes
|
90.7 percentage of eyes
|
96.2 percentage of eyes
|
92.6 percentage of eyes
|
95.4 percentage of eyes
|
96.3 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Nasal - Trace
|
9.3 percentage of eyes
|
7.4 percentage of eyes
|
3.8 percentage of eyes
|
5.6 percentage of eyes
|
3.7 percentage of eyes
|
3.7 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Nasal - Mild
|
0.0 percentage of eyes
|
1.9 percentage of eyes
|
0.0 percentage of eyes
|
1.9 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Nasal - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Nasal - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Inferior - None
|
70.4 percentage of eyes
|
70.4 percentage of eyes
|
71.7 percentage of eyes
|
74.1 percentage of eyes
|
67.6 percentage of eyes
|
70.4 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Inferior - Trace
|
29.6 percentage of eyes
|
28.7 percentage of eyes
|
21.7 percentage of eyes
|
17.6 percentage of eyes
|
23.1 percentage of eyes
|
23.1 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Inferior - Mild
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
6.6 percentage of eyes
|
8.3 percentage of eyes
|
9.3 percentage of eyes
|
6.5 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Inferior - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Inferior - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Central - None
|
94.4 percentage of eyes
|
88.9 percentage of eyes
|
88.7 percentage of eyes
|
88.0 percentage of eyes
|
95.4 percentage of eyes
|
88.9 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Central - Trace
|
5.6 percentage of eyes
|
11.1 percentage of eyes
|
10.4 percentage of eyes
|
11.1 percentage of eyes
|
2.8 percentage of eyes
|
11.1 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Fanfilcon A Lens (Test)
Central - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Corneal Staining - Enfilcon A Lens (Control)
Superior - None
|
75.9 percentage of eyes
|
84.6 percentage of eyes
|
96.6 percentage of eyes
|
93.1 percentage of eyes
|
78.6 percentage of eyes
|
93.1 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Superior - Trace
|
24.1 percentage of eyes
|
15.4 percentage of eyes
|
3.4 percentage of eyes
|
6.9 percentage of eyes
|
21.4 percentage of eyes
|
6.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Superior - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Superior - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Temporal - None
|
65.5 percentage of eyes
|
84.6 percentage of eyes
|
75.9 percentage of eyes
|
89.7 percentage of eyes
|
75.0 percentage of eyes
|
89.6 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Temporal - Trace
|
34.5 percentage of eyes
|
15.4 percentage of eyes
|
24.1 percentage of eyes
|
10.3 percentage of eyes
|
25.0 percentage of eyes
|
10.3 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Temporal - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
6.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Central - None
|
62.1 percentage of eyes
|
73.1 percentage of eyes
|
79.3 percentage of eyes
|
75.8 percentage of eyes
|
85.7 percentage of eyes
|
82.8 percentage of eyes
|
83.4 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Central - Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
3.4 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
8.3 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Central - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Central - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Nasal - None
|
62.1 percentage of eyes
|
73.0 percentage of eyes
|
65.5 percentage of eyes
|
79.3 percentage of eyes
|
78.6 percentage of eyes
|
75.9 percentage of eyes
|
100.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Inferior - None
|
51.7 percentage of eyes
|
57.6 percentage of eyes
|
27.6 percentage of eyes
|
62.0 percentage of eyes
|
53.5 percentage of eyes
|
44.8 percentage of eyes
|
66.7 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Inferior - Trace
|
48.3 percentage of eyes
|
42.3 percentage of eyes
|
72.4 percentage of eyes
|
37.9 percentage of eyes
|
46.4 percentage of eyes
|
55.2 percentage of eyes
|
33.3 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Inferior - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Superior - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Temporal - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Temporal - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Central - Trace
|
37.9 percentage of eyes
|
26.9 percentage of eyes
|
20.7 percentage of eyes
|
24.1 percentage of eyes
|
14.3 percentage of eyes
|
17.2 percentage of eyes
|
8.3 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Nasal - Trace
|
37.9 percentage of eyes
|
26.9 percentage of eyes
|
34.5 percentage of eyes
|
20.7 percentage of eyes
|
21.4 percentage of eyes
|
24.1 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Nasal - Mild
|
0.0 percentage of eyes
|
3.8 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
1.8 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Nasal - Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Nasal - Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Inferior - Mild
|
0.0 percentage of eyes
|
7.7 percentage of eyes
|
3.4 percentage of eyes
|
10.3 percentage of eyes
|
3.6 percentage of eyes
|
3.4 percentage of eyes
|
0.0 percentage of eyes
|
|
Corneal Staining - Enfilcon A Lens (Control)
Inferior - Superior
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Limbal Hyperemia - Fanfilcon A Lens (Test)
None
|
80.6 percentage of eyes
|
88.9 percentage of eyes
|
76.4 percentage of eyes
|
80.6 percentage of eyes
|
82.4 percentage of eyes
|
75.9 percentage of eyes
|
100.0 percentage of eyes
|
|
Limbal Hyperemia - Fanfilcon A Lens (Test)
Trace
|
19.4 percentage of eyes
|
11.1 percentage of eyes
|
23.6 percentage of eyes
|
19.4 percentage of eyes
|
17.6 percentage of eyes
|
23.1 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Fanfilcon A Lens (Test)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Fanfilcon A Lens (Test)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Fanfilcon A Lens (Test)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Limbal Hyperemia - Enfilcon A Lens (Control)
None
|
79.3 percentage of eyes
|
80.8 percentage of eyes
|
93.1 percentage of eyes
|
93.1 percentage of eyes
|
92.9 percentage of eyes
|
87.9 percentage of eyes
|
100.0 percentage of eyes
|
|
Limbal Hyperemia - Enfilcon A Lens (Control)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Enfilcon A Lens (Control)
Trace
|
20.7 percentage of eyes
|
19.2 percentage of eyes
|
6.9 percentage of eyes
|
6.9 percentage of eyes
|
7.1 percentage of eyes
|
10.3 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Enfilcon A Lens (Control)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
1.7 percentage of eyes
|
0.0 percentage of eyes
|
|
Limbal Hyperemia - Enfilcon A Lens (Control)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Bulbar Hyperemia - Fanfilcon A Lens (Test)
Trace
|
39.8 percentage of eyes
|
21.3 percentage of eyes
|
32.1 percentage of eyes
|
31.5 percentage of eyes
|
26.9 percentage of eyes
|
29.6 percentage of eyes
|
33.3 percentage of eyes
|
|
Bulbar Hyperemia - Fanfilcon A Lens (Test)
Mild
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.9 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Fanfilcon A Lens (Test)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Fanfilcon A Lens (Test)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Fanfilcon A Lens (Test)
None
|
60.2 percentage of eyes
|
77.8 percentage of eyes
|
67.0 percentage of eyes
|
68.5 percentage of eyes
|
73.1 percentage of eyes
|
69.4 percentage of eyes
|
66.7 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Bulbar Hyperemia - Enfilcon A Lens (Control)
None
|
65.5 percentage of eyes
|
61.5 percentage of eyes
|
72.4 percentage of eyes
|
69.0 percentage of eyes
|
92.9 percentage of eyes
|
81.0 percentage of eyes
|
100.0 percentage of eyes
|
|
Bulbar Hyperemia - Enfilcon A Lens (Control)
Trace
|
34.5 percentage of eyes
|
38.5 percentage of eyes
|
27.6 percentage of eyes
|
31.0 percentage of eyes
|
7.1 percentage of eyes
|
17.2 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Enfilcon A Lens (Control)
Mild
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
1.7 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Enfilcon A Lens (Control)
Moderate
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Bulbar Hyperemia - Enfilcon A Lens (Control)
Severe
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Palpebral Conjunctiva - Fanfilcon A Lens (Test)
Absent
|
69.4 percentage of eyes
|
64.8 percentage of eyes
|
63.2 percentage of eyes
|
67.6 percentage of eyes
|
60.2 percentage of eyes
|
58.3 percentage of eyes
|
50.0 percentage of eyes
|
|
Palpebral Conjunctiva - Fanfilcon A Lens (Test)
Present
|
30.6 percentage of eyes
|
35.2 percentage of eyes
|
36.8 percentage of eyes
|
32.4 percentage of eyes
|
39.8 percentage of eyes
|
41.7 percentage of eyes
|
50.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Palpebral Conjunctiva - Enfilcon A Lens (Control)
Absent
|
55.2 percentage of eyes
|
69.2 percentage of eyes
|
62.1 percentage of eyes
|
58.6 percentage of eyes
|
67.9 percentage of eyes
|
67.2 percentage of eyes
|
66.7 percentage of eyes
|
|
Palpebral Conjunctiva - Enfilcon A Lens (Control)
Present
|
44.8 percentage of eyes
|
30.8 percentage of eyes
|
37.9 percentage of eyes
|
41.4 percentage of eyes
|
32.1 percentage of eyes
|
32.8 percentage of eyes
|
33.3 percentage of eyes
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit.
Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.
Outcome measures
| Measure |
Baseline
n=108 Eyes
fanfilcon A lens (test)
|
Week 1
n=106 Eyes
fanfilcon A lens (test)
|
Week 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
fanfilcon A lens (test)
|
Unscheduled
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/15
|
27 eyes
|
26 eyes
|
27 eyes
|
27 eyes
|
27 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/20
|
78 eyes
|
77 eyes
|
78 eyes
|
78 eyes
|
78 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/25
|
3 eyes
|
3 eyes
|
3 eyes
|
3 eyes
|
3 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/30
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/40
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/50
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Fanfilcon A Lens (Test)
20/60
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit.
Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.
Outcome measures
| Measure |
Baseline
n=52 Eyes
fanfilcon A lens (test)
|
Week 1
n=58 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=56 Eyes
fanfilcon A lens (test)
|
Month 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 3
fanfilcon A lens (test)
|
Unscheduled
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Visual Acuity - Enfilcon A Lens (Control)
20/50
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/15
|
14 eyes
|
14 eyes
|
14 eyes
|
14 eyes
|
14 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/20
|
36 eyes
|
42 eyes
|
42 eyes
|
40 eyes
|
42 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/25
|
2 eyes
|
2 eyes
|
2 eyes
|
2 eyes
|
2 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/30
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/40
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Visual Acuity - Enfilcon A Lens (Control)
20/60
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Average lens wearing time for fanfilcon A lens (test) measured in hours.
Outcome measures
| Measure |
Baseline
n=54 Participants
fanfilcon A lens (test)
|
Week 1
n=54 Participants
fanfilcon A lens (test)
|
Week 2
n=53 Participants
fanfilcon A lens (test)
|
Month 1
n=54 Participants
fanfilcon A lens (test)
|
Month 2
n=54 Participants
fanfilcon A lens (test)
|
Month 3
n=54 Participants
fanfilcon A lens (test)
|
Unscheduled
n=2 Participants
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Average Wearing Time - Fanfilcon A Lens (Test)
|
14.17 hours
Standard Deviation 4.24
|
13.25 hours
Standard Deviation 2.56
|
13.08 hours
Standard Deviation 2.23
|
13.18 hours
Standard Deviation 2.59
|
13.21 hours
Standard Deviation 2.41
|
13.13 hours
Standard Deviation 2.61
|
16.50 hours
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Average lens wearing time for enfilcon A lens (control) measured in hours.
Outcome measures
| Measure |
Baseline
n=29 Participants
fanfilcon A lens (test)
|
Week 1
n=26 Participants
fanfilcon A lens (test)
|
Week 2
n=29 Participants
fanfilcon A lens (test)
|
Month 1
n=29 Participants
fanfilcon A lens (test)
|
Month 2
n=28 Participants
fanfilcon A lens (test)
|
Month 3
n=29 Participants
fanfilcon A lens (test)
|
Unscheduled
n=3 Participants
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Average Wearing Time - Enfilcon A Lens (Control)
|
13.81 hours
Standard Deviation 2.95
|
13.67 hours
Standard Deviation 2.58
|
13.41 hours
Standard Deviation 2.28
|
13.52 hours
Standard Deviation 2.11
|
13.20 hours
Standard Deviation 2.50
|
13.62 hours
Standard Deviation 2.35
|
12.67 hours
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Outcome measures
| Measure |
Baseline
n=54 Participants
fanfilcon A lens (test)
|
Week 1
n=108 Eyes
fanfilcon A lens (test)
|
Week 2
n=106 Eyes
fanfilcon A lens (test)
|
Month 1
n=108 Eyes
fanfilcon A lens (test)
|
Month 2
n=108 Eyes
fanfilcon A lens (test)
|
Month 3
n=108 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Comfort - Fanfilcon A Lens (Test)
CUI - comfortable
|
15 Eyes
|
6 Eyes
|
6 Eyes
|
10 Eyes
|
6 Eyes
|
2 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD - very comfortable
|
38 Eyes
|
50 Eyes
|
47 Eyes
|
40 Eyes
|
48 Eyes
|
50 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - causes pain
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CUI - excellent
|
50 Eyes
|
50 Eyes
|
67 Eyes
|
61 Eyes
|
60 Eyes
|
64 Eyes
|
4 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CUI - very comfortable
|
40 Eyes
|
50 Eyes
|
29 Eyes
|
36 Eyes
|
40 Eyes
|
40 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CUI- slightly uncomfortable
|
3 Eyes
|
2 Eyes
|
4 Eyes
|
1 Eyes
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CUI - very uncomfortable
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CUI - causes pain
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD - excellent
|
45 Eyes
|
45 Eyes
|
48 Eyes
|
50 Eyes
|
48 Eyes
|
48 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD - comfortable
|
19 Eyes
|
13 Eyes
|
9 Eyes
|
9 Eyes
|
8 Eyes
|
6 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD - slightly uncomfortable
|
6 Eyes
|
0 Eyes
|
0 Eyes
|
9 Eyes
|
4 Eyes
|
4 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD-very uncomfortable
|
0 Eyes
|
0 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CDD - causes pain
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - excellent
|
14 Eyes
|
32 Eyes
|
31 Eyes
|
30 Eyes
|
36 Eyes
|
30 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - very comfortable
|
46 Eyes
|
34 Eyes
|
43 Eyes
|
38 Eyes
|
32 Eyes
|
44 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - comfortable
|
27 Eyes
|
32 Eyes
|
30 Eyes
|
22 Eyes
|
25 Eyes
|
24 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - slightly uncomfortable
|
19 Eyes
|
8 Eyes
|
2 Eyes
|
16 Eyes
|
11 Eyes
|
8 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - very uncomfortable
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
2 Eyes
|
4 Eyes
|
2 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
EDC - causes pain
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - excellent
|
37 Eyes
|
40 Eyes
|
40 Eyes
|
43 Eyes
|
46 Eyes
|
46 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - very comfortable
|
47 Eyes
|
58 Eyes
|
54 Eyes
|
44 Eyes
|
42 Eyes
|
48 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - comfortable
|
20 Eyes
|
8 Eyes
|
10 Eyes
|
14 Eyes
|
14 Eyes
|
8 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - slightly uncomfortable
|
4 Eyes
|
2 Eyes
|
0 Eyes
|
7 Eyes
|
6 Eyes
|
6 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - very uncomfortable
|
0 Eyes
|
0 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
OC - causes pain
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - excellent
|
60 Eyes
|
60 Eyes
|
63 Eyes
|
56 Eyes
|
56 Eyes
|
62 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - very comfortable
|
22 Eyes
|
36 Eyes
|
30 Eyes
|
38 Eyes
|
36 Eyes
|
34 Eyes
|
2 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - comfortable
|
17 Eyes
|
12 Eyes
|
11 Eyes
|
6 Eyes
|
12 Eyes
|
8 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - slightly uncomfortable
|
7 Eyes
|
0 Eyes
|
0 Eyes
|
6 Eyes
|
4 Eyes
|
4 Eyes
|
0 Eyes
|
|
Comfort - Fanfilcon A Lens (Test)
CV - very uncomfortable
|
2 Eyes
|
0 Eyes
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-upPopulation: All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Outcome measures
| Measure |
Baseline
n=58 eyes
fanfilcon A lens (test)
|
Week 1
n=52 eyes
fanfilcon A lens (test)
|
Week 2
n=58 eyes
fanfilcon A lens (test)
|
Month 1
n=58 eyes
fanfilcon A lens (test)
|
Month 2
n=56 eyes
fanfilcon A lens (test)
|
Month 3
n=58 eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Comfort - Enfilcon A Lens (Control)
CUI - very comfortable
|
26 eyes
|
23 eyes
|
16 eyes
|
24 eyes
|
12 eyes
|
18 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CUI - comfortable
|
6 eyes
|
6 eyes
|
12 eyes
|
11 eyes
|
12 eyes
|
12 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CUI- slightly uncomfortable
|
6 eyes
|
7 eyes
|
0 eyes
|
3 eyes
|
4 eyes
|
2 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD - very comfortable
|
18 eyes
|
15 eyes
|
13 eyes
|
10 eyes
|
17 eyes
|
18 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD - slightly uncomfortable
|
2 eyes
|
3 eyes
|
2 eyes
|
10 eyes
|
4 eyes
|
9 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - slightly uncomfortable
|
8 eyes
|
2 eyes
|
2 eyes
|
2 eyes
|
4 eyes
|
3 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CUI - very uncomfortable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CUI - causes pain
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD - excellent
|
26 eyes
|
22 eyes
|
24 eyes
|
18 eyes
|
22 eyes
|
19 eyes
|
6 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD - comfortable
|
12 eyes
|
12 eyes
|
19 eyes
|
20 eyes
|
13 eyes
|
10 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD-very uncomfortable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CDD - causes pain
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - excellent
|
16 eyes
|
12 eyes
|
22 eyes
|
14 eyes
|
16 eyes
|
14 eyes
|
6 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - very comfortable
|
12 eyes
|
14 eyes
|
5 eyes
|
8 eyes
|
15 eyes
|
12 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - comfortable
|
14 eyes
|
10 eyes
|
24 eyes
|
20 eyes
|
15 eyes
|
10 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - slightly uncomfortable
|
10 eyes
|
14 eyes
|
7 eyes
|
12 eyes
|
8 eyes
|
19 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - very uncomfortable
|
6 eyes
|
2 eyes
|
0 eyes
|
4 eyes
|
2 eyes
|
3 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
EDC - causes pain
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC - excellent
|
20 eyes
|
16 eyes
|
20 eyes
|
18 eyes
|
24 eyes
|
18 eyes
|
4 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC - very comfortable
|
24 eyes
|
16 eyes
|
19 eyes
|
12 eyes
|
12 eyes
|
16 eyes
|
2 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC- comfortable
|
10 eyes
|
10 eyes
|
16 eyes
|
22 eyes
|
14 eyes
|
16 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC - slightly uncomfortable
|
4 eyes
|
10 eyes
|
3 eyes
|
6 eyes
|
6 eyes
|
6 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC - very uncomfortable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
OC - causes pain
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - excellent
|
22 eyes
|
28 eyes
|
32 eyes
|
26 eyes
|
32 eyes
|
22 eyes
|
4 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - very comfortable
|
16 eyes
|
14 eyes
|
8 eyes
|
16 eyes
|
8 eyes
|
22 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - comfortable
|
12 eyes
|
8 eyes
|
16 eyes
|
14 eyes
|
12 eyes
|
11 eyes
|
2 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - very uncomfortable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CV - causes pain
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Comfort - Enfilcon A Lens (Control)
CUI - excellent
|
20 eyes
|
16 eyes
|
30 eyes
|
20 eyes
|
28 eyes
|
26 eyes
|
6 eyes
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Outcome measures
| Measure |
Baseline
n=108 eyes
fanfilcon A lens (test)
|
Week 1
n=108 eyes
fanfilcon A lens (test)
|
Week 2
n=106 eyes
fanfilcon A lens (test)
|
Month 1
n=108 eyes
fanfilcon A lens (test)
|
Month 2
n=108 eyes
fanfilcon A lens (test)
|
Month 3
n=108 eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - excellent
|
53 eyes
|
70 eyes
|
68 eyes
|
64 eyes
|
64 eyes
|
70 eyes
|
4 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - very good
|
41 eyes
|
30 eyes
|
27 eyes
|
28 eyes
|
30 eyes
|
32 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - good
|
8 eyes
|
8 eyes
|
9 eyes
|
16 eyes
|
11 eyes
|
4 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - poor
|
6 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
2 eyes
|
2 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - very poor
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
OVC - unacceptable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
1 eyes
|
0 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - excellent
|
41 eyes
|
60 eyes
|
58 eyes
|
50 eyes
|
52 eyes
|
60 eyes
|
4 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - very good
|
33 eyes
|
34 eyes
|
32 eyes
|
32 eyes
|
34 eyes
|
32 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - good
|
28 eyes
|
14 eyes
|
14 eyes
|
26 eyes
|
22 eyes
|
12 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - poor
|
4 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
4 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - very poor
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Overall Vision Quality - Fanfilcon A Lens (Test)
VAN - unacceptable
|
2 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Outcome measures
| Measure |
Baseline
n=29 Participants
fanfilcon A lens (test)
|
Week 1
n=52 eyes
fanfilcon A lens (test)
|
Week 2
n=58 eyes
fanfilcon A lens (test)
|
Month 1
n=58 eyes
fanfilcon A lens (test)
|
Month 2
n=56 eyes
fanfilcon A lens (test)
|
Month 3
n=58 eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - excellent
|
23 eyes
|
28 eyes
|
28 eyes
|
22 eyes
|
30 eyes
|
25 eyes
|
4 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - very good
|
24 eyes
|
10 eyes
|
17 eyes
|
20 eyes
|
15 eyes
|
16 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - good
|
11 eyes
|
12 eyes
|
12 eyes
|
14 eyes
|
9 eyes
|
12 eyes
|
2 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - poor
|
0 eyes
|
2 eyes
|
1 eyes
|
2 eyes
|
0 eyes
|
4 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - very poor
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
2 eyes
|
1 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
OVC - unacceptable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN - excellent
|
13 eyes
|
26 eyes
|
28 eyes
|
22 eyes
|
20 eyes
|
20 eyes
|
4 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN - very good
|
26 eyes
|
12 eyes
|
15 eyes
|
18 eyes
|
21 eyes
|
16 eyes
|
2 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN - good
|
19 eyes
|
12 eyes
|
14 eyes
|
14 eyes
|
11 eyes
|
18 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN - poor
|
0 eyes
|
2 eyes
|
1 eyes
|
4 eyes
|
2 eyes
|
4 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN - very poor
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
|
Overall Vision Quality - Enfilcon A Lens (Control)
VAN- unacceptable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
Outcome measures
| Measure |
Baseline
n=108 eyes
fanfilcon A lens (test)
|
Week 1
n=108 eyes
fanfilcon A lens (test)
|
Week 2
n=106 eyes
fanfilcon A lens (test)
|
Month 1
n=108 eyes
fanfilcon A lens (test)
|
Month 2
n=108 eyes
fanfilcon A lens (test)
|
Month 3
n=108 eyes
fanfilcon A lens (test)
|
Unscheduled
n=4 eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - excellent
|
78 eyes
|
70 eyes
|
72 eyes
|
73 eyes
|
68 eyes
|
72 eyes
|
2 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - very good
|
26 eyes
|
34 eyes
|
30 eyes
|
30 eyes
|
34 eyes
|
32 eyes
|
2 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - good
|
4 eyes
|
4 eyes
|
2 eyes
|
2 eyes
|
6 eyes
|
4 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - poor
|
0 eyes
|
0 eyes
|
0 eyes
|
3 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - very poor
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOI - unmanageable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - excellent
|
72 eyes
|
62 eyes
|
57 eyes
|
48 eyes
|
58 eyes
|
56 eyes
|
2 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - very good
|
28 eyes
|
31 eyes
|
33 eyes
|
43 eyes
|
30 eyes
|
30 eyes
|
2 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - good
|
8 eyes
|
11 eyes
|
12 eyes
|
15 eyes
|
18 eyes
|
22 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - poor
|
0 eyes
|
4 eyes
|
2 eyes
|
2 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - very poor
|
0 eyes
|
0 eyes
|
2 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
|
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
EOR - unmanageable
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Population: All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
Outcome measures
| Measure |
Baseline
n=58 Eyes
fanfilcon A lens (test)
|
Week 1
n=52 Eyes
fanfilcon A lens (test)
|
Week 2
n=58 Eyes
fanfilcon A lens (test)
|
Month 1
n=58 Eyes
fanfilcon A lens (test)
|
Month 2
n=56 Eyes
fanfilcon A lens (test)
|
Month 3
n=58 Eyes
fanfilcon A lens (test)
|
Unscheduled
n=6 Eyes
fanfilcon A lens (test)
|
|---|---|---|---|---|---|---|---|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - excellent
|
34 Eyes
|
31 Eyes
|
36 Eyes
|
30 Eyes
|
36 Eyes
|
30 Eyes
|
6 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - very good
|
12 Eyes
|
14 Eyes
|
12 Eyes
|
16 Eyes
|
10 Eyes
|
17 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - good
|
10 Eyes
|
5 Eyes
|
10 Eyes
|
10 Eyes
|
6 Eyes
|
7 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - poor
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
2 Eyes
|
4 Eyes
|
4 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - very poor
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOI - unmanageable
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - excellent
|
40 Eyes
|
36 Eyes
|
40 Eyes
|
34 Eyes
|
36 Eyes
|
34 Eyes
|
6 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - very good
|
12 Eyes
|
12 Eyes
|
12 Eyes
|
16 Eyes
|
16 Eyes
|
14 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - good
|
6 Eyes
|
2 Eyes
|
5 Eyes
|
8 Eyes
|
4 Eyes
|
10 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - poor
|
0 Eyes
|
1 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - very poor
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Ease of Insertion and Removal - Enfilcon A Lens (Control)
EOR - unmanageable
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
Adverse Events
Fanfilcon A (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enfilcon A (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER