Trial Outcomes & Findings for Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses (NCT NCT02542072)
NCT ID: NCT02542072
Last Updated: 2017-10-24
Results Overview
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Baseline, 2 weeks, 4 weeks
Results posted on
2017-10-24
Participant Flow
Participant milestones
| Measure |
Comfilcon A, Then Samfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.
comfilcon A: contact lens
samfilcon A: contact lens
|
Samfilcon A, Then Comfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.
samfilcon A: contact lens
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention (1 Month)
STARTED
|
44
|
46
|
|
First Intervention (1 Month)
COMPLETED
|
39
|
43
|
|
First Intervention (1 Month)
NOT COMPLETED
|
5
|
3
|
|
Second Intervention (1 Month)
STARTED
|
39
|
43
|
|
Second Intervention (1 Month)
COMPLETED
|
37
|
43
|
|
Second Intervention (1 Month)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Comfilcon A, Then Samfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.
comfilcon A: contact lens
samfilcon A: contact lens
|
Samfilcon A, Then Comfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.
samfilcon A: contact lens
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention (1 Month)
Adverse Event
|
1
|
1
|
|
First Intervention (1 Month)
Lost to Follow-up
|
2
|
0
|
|
First Intervention (1 Month)
Lens discomfort
|
1
|
2
|
|
First Intervention (1 Month)
Protocol Violation
|
1
|
0
|
|
Second Intervention (1 Month)
Lost to Follow-up
|
1
|
0
|
|
Second Intervention (1 Month)
Lens discomfort
|
1
|
0
|
Baseline Characteristics
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Baseline characteristics by cohort
| Measure |
Comfilcon A, Then Samfilcon A
n=44 Participants
Randomized participants who wore the comfilcon A lens pair for one month, then samfilcon A lens pair during the cross over study.
comfilcon A: contact lenses
samfilcon A: contact lenses
|
Samfilcon A, Then Comfilcon A
n=46 Participants
Randomized participants who wore the samfilcon A lens pair for one month, then comfilcon A lens pair during the cross over study.
comfilcon A: contact lenses
samfilcon A: contact lenses
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
30.8 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
31.4 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksPopulation: Number of participants analyzed is different from participant flow due to protocol deviations.
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Comfort
Comfort after insertion
|
8.85 units on a scale
Standard Deviation 1.92
|
9.06 units on a scale
Standard Deviation 1.40
|
8.71 units on a scale
Standard Deviation 1.81
|
8.84 units on a scale
Standard Deviation 1.56
|
8.60 units on a scale
Standard Deviation 1.80
|
—
|
|
Comfort
Typical comfort just prior to removal
|
7.72 units on a scale
Standard Deviation 2.06
|
7.68 units on a scale
Standard Deviation 2.11
|
7.09 units on a scale
Standard Deviation 2.30
|
7.38 units on a scale
Standard Deviation 2.32
|
6.94 units on a scale
Standard Deviation 2.22
|
—
|
|
Comfort
Overall comfort
|
8.80 units on a scale
Standard Deviation 1.75
|
8.33 units on a scale
Standard Deviation 1.81
|
7.90 units on a scale
Standard Deviation 1.90
|
8.01 units on a scale
Standard Deviation 1.95
|
7.76 units on a scale
Standard Deviation 1.76
|
—
|
SECONDARY outcome
Timeframe: Days 3, 12, 26Population: Number of participants analyzed may differ from participant flow due to protocol deviations.
Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=85 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=85 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=83 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=84 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Comfortable Wearing Time Via SMS (Short Message Service)
8:00 am
|
8.59 units on a scale
Standard Deviation 1.85
|
8.82 units on a scale
Standard Deviation 1.61
|
8.90 units on a scale
Standard Deviation 1.46
|
8.84 units on a scale
Standard Deviation 1.36
|
8.98 units on a scale
Standard Deviation 1.45
|
8.51 units on a scale
Standard Deviation 1.67
|
|
Comfortable Wearing Time Via SMS (Short Message Service)
12:00 pm
|
8.97 units on a scale
Standard Deviation 1.26
|
9.07 units on a scale
Standard Deviation 1.03
|
8.71 units on a scale
Standard Deviation 1.87
|
8.55 units on a scale
Standard Deviation 1.83
|
8.44 units on a scale
Standard Deviation 1.74
|
8.11 units on a scale
Standard Deviation 2.12
|
|
Comfortable Wearing Time Via SMS (Short Message Service)
4:00 pm
|
8.56 units on a scale
Standard Deviation 1.80
|
8.65 units on a scale
Standard Deviation 1.53
|
8.19 units on a scale
Standard Deviation 1.84
|
8.03 units on a scale
Standard Deviation 1.98
|
8.06 units on a scale
Standard Deviation 1.85
|
8.07 units on a scale
Standard Deviation 1.63
|
|
Comfortable Wearing Time Via SMS (Short Message Service)
8:00 pm
|
8.53 units on a scale
Standard Deviation 1.52
|
8.30 units on a scale
Standard Deviation 1.59
|
8.06 units on a scale
Standard Deviation 1.93
|
7.84 units on a scale
Standard Deviation 2.21
|
7.87 units on a scale
Standard Deviation 2.25
|
7.82 units on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksAverage wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Wearing Times
Average wearing time
|
6.16 hours
Standard Deviation 1.37
|
13.94 hours
Standard Deviation 1.82
|
13.68 hours
Standard Deviation 2.46
|
13.90 hours
Standard Deviation 2.18
|
13.93 hours
Standard Deviation 2.11
|
—
|
|
Wearing Times
Comfortable wearing time
|
12.79 hours
Standard Deviation 2.64
|
11.58 hours
Standard Deviation 3.05
|
11.28 hours
Standard Deviation 3.84
|
11.34 hours
Standard Deviation 3.48
|
11.02 hours
Standard Deviation 3.63
|
—
|
|
Wearing Times
Maximum wearing time
|
16.59 hours
Standard Deviation 2.90
|
16.15 hours
Standard Deviation 2.39
|
15.48 hours
Standard Deviation 2.48
|
16.04 hours
Standard Deviation 2.44
|
15.91 hours
Standard Deviation 2.35
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksDeterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Deterioration in Comfort
Yes=deterioration in comfort present
|
47 participants
|
51 participants
|
46 participants
|
53 participants
|
52 participants
|
—
|
|
Deterioration in Comfort
No=deterioration in comfort absent
|
43 participants
|
31 participants
|
36 participants
|
29 participants
|
28 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksPopulation: Number of participants analyzed differ from participant flow due to protocol deviations.
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Vision Quality
|
9.31 units on a scale
Standard Deviation 1.10
|
9.06 units on a scale
Standard Deviation 1.15
|
8.49 units on a scale
Standard Deviation 1.81
|
8.81 units on a scale
Standard Deviation 1.55
|
8.34 units on a scale
Standard Deviation 1.79
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksHandling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Overall Lens Handling
Ease of insertion
|
9.31 units on a scale
Standard Deviation 1.40
|
9.12 units on a scale
Standard Deviation 1.56
|
8.96 units on a scale
Standard Deviation 1.69
|
9.18 units on a scale
Standard Deviation 1.48
|
8.83 units on a scale
Standard Deviation 1.73
|
—
|
|
Overall Lens Handling
Ease of removal
|
9.31 units on a scale
Standard Deviation 1.38
|
8.94 units on a scale
Standard Deviation 1.84
|
9.06 units on a scale
Standard Deviation 1.53
|
8.86 units on a scale
Standard Deviation 2.14
|
8.98 units on a scale
Standard Deviation 1.48
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksBiomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=180 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Biomicroscopy Scores
Limbal Hyperaemia
|
0.39 units on a scale
Standard Deviation 0.39
|
0.42 units on a scale
Standard Deviation 0.50
|
0.45 units on a scale
Standard Deviation 0.45
|
0.47 units on a scale
Standard Deviation 0.48
|
0.49 units on a scale
Standard Deviation 0.46
|
—
|
|
Biomicroscopy Scores
Bulbar Hyperaemia
|
0.67 units on a scale
Standard Deviation 0.53
|
0.60 units on a scale
Standard Deviation 0.58
|
0.67 units on a scale
Standard Deviation 0.57
|
0.61 units on a scale
Standard Deviation 0.57
|
0.62 units on a scale
Standard Deviation 0.52
|
—
|
|
Biomicroscopy Scores
Palpebral Conjunctiva
|
0.53 units on a scale
Standard Deviation 0.59
|
0.73 units on a scale
Standard Deviation 0.75
|
0.72 units on a scale
Standard Deviation 0.85
|
0.79 units on a scale
Standard Deviation 0.77
|
0.78 units on a scale
Standard Deviation 0.79
|
—
|
|
Biomicroscopy Scores
Corneal Staining
|
0.39 units on a scale
Standard Deviation 0.55
|
0.63 units on a scale
Standard Deviation 0.66
|
0.56 units on a scale
Standard Deviation 0.63
|
0.69 units on a scale
Standard Deviation 0.70
|
0.56 units on a scale
Standard Deviation 0.72
|
—
|
|
Biomicroscopy Scores
Conjunctival fluorescein staining
|
0.67 units on a scale
Standard Deviation 0.61
|
0.75 units on a scale
Standard Deviation 0.66
|
1.23 units on a scale
Standard Deviation 0.69
|
0.81 units on a scale
Standard Deviation 0.67
|
1.19 units on a scale
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksLens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Lens Surface Wetting
|
3.69 units on a scale
Standard Deviation 0.51
|
3.61 units on a scale
Standard Deviation 0.57
|
3.51 units on a scale
Standard Deviation 0.56
|
3.37 units on a scale
Standard Deviation 0.70
|
3.27 units on a scale
Standard Deviation 0.85
|
3.22 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 2 weeks and 4 weeksFront surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=164 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=160 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Film Deposits
|
0.12 units on a scale
Standard Deviation 0.32
|
0.26 units on a scale
Standard Deviation 0.63
|
0.35 units on a scale
Standard Deviation 0.73
|
0.30 units on a scale
Standard Deviation 0.63
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeks and 4 weeksNumber of white spot deposits for comfilcon A and samfilcon A lenses.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=164 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=160 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
White Spot Deposits
|
0.3 number of white spots
Standard Deviation 1.0
|
0.4 number of white spots
Standard Deviation 1.4
|
0.8 number of white spots
Standard Deviation 2.6
|
0.7 number of white spots
Standard Deviation 2.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksVisual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Visual Acuity (VA)
Binocular Distance Visual Acuity
|
-0.07 LogMAR
Standard Deviation 0.09
|
-0.08 LogMAR
Standard Deviation 0.10
|
-0.07 LogMAR
Standard Deviation 0.09
|
-0.08 LogMAR
Standard Deviation 0.10
|
-0.07 LogMAR
Standard Deviation 0.10
|
—
|
|
Visual Acuity (VA)
Distance Visual Acuity
|
-0.03 LogMAR
Standard Deviation 0.08
|
-0.04 LogMAR
Standard Deviation 0.10
|
-0.01 LogMAR
Standard Deviation 0.10
|
-0.03 LogMAR
Standard Deviation 0.10
|
-0.02 LogMAR
Standard Deviation 0.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksLens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (\>0.5mm)
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Lens Centration
Centered - optimal
|
173 Eyes
|
153 Eyes
|
162 Eyes
|
152 Eyes
|
163 Eyes
|
156 Eyes
|
|
Lens Centration
Decentered slightly
|
1 Eyes
|
16 Eyes
|
2 Eyes
|
12 Eyes
|
1 Eyes
|
4 Eyes
|
|
Lens Centration
Substantially decentered
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks follow-up, 4-weeks follow-upInvestigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Corneal Coverage
Yes
|
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 Coverage
No
|
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
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksPost-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Post-Blink Movement
|
1.91 units on a scale
Standard Deviation 0.55
|
1.86 units on a scale
Standard Deviation 0.58
|
1.84 units on a scale
Standard Deviation 0.51
|
1.79 units on a scale
Standard Deviation 0.58
|
1.87 units on a scale
Standard Deviation 0.42
|
1.69 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, and 4 weeksInvestigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Primary Gaze Lag
|
1.89 units on a scale
Standard Deviation 0.55
|
1.82 units on a scale
Standard Deviation 0.63
|
1.78 units on a scale
Standard Deviation 0.54
|
1.69 units on a scale
Standard Deviation 0.56
|
1.88 units on a scale
Standard Deviation 0.48
|
1.71 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksInvestigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses. Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=174 Eyes
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=170 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=164 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=160 Eyes
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Lens Tightness Push-up
|
48.9 percentage of mean lens tightness
Standard Deviation 10.8
|
54.3 percentage of mean lens tightness
Standard Deviation 11.9
|
50.6 percentage of mean lens tightness
Standard Deviation 10.4
|
54.1 percentage of mean lens tightness
Standard Deviation 9.9
|
50.3 percentage of mean lens tightness
Standard Deviation 8.2
|
54.6 percentage of mean lens tightness
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksOverall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=87 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=85 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Overall Fit Acceptance
|
3.71 units on a scale
Standard Deviation 0.45
|
3.63 units on a scale
Standard Deviation 0.48
|
3.73 units on a scale
Standard Deviation 0.44
|
3.63 units on a scale
Standard Deviation 0.48
|
3.78 units on a scale
Standard Deviation 0.42
|
3.66 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksSubjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry
Outcome measures
| Measure |
Habitual Lens (Baseline)
n=90 Participants
Habitual data were collected of participants before lens dispensed.
|
Comfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (2 Weeks)
n=82 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Comfilcon A (4 Weeks)
n=82 Participants
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens
|
Samfilcon A (4 Weeks)
n=80 Participants
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
Samfilcon A (Day 26)
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens
|
|---|---|---|---|---|---|---|
|
Dryness
During a typical day of wear
|
8.06 units on a scale
Standard Deviation 2.24
|
7.98 units on a scale
Standard Deviation 1.91
|
7.46 units on a scale
Standard Deviation 2.12
|
7.71 units on a scale
Standard Deviation 2.13
|
7.18 units on a scale
Standard Deviation 2.22
|
—
|
|
Dryness
Prior to removal
|
7.57 units on a scale
Standard Deviation 2.26
|
7.61 units on a scale
Standard Deviation 2.12
|
6.83 units on a scale
Standard Deviation 2.49
|
7.27 units on a scale
Standard Deviation 2.49
|
6.60 units on a scale
Standard Deviation 2.44
|
—
|
Adverse Events
Comfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Samfilcon A
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
Sr. Manager Global Medical Scientific Affairs
CooperVision Inc.
Phone: (925) 621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER