Trial Outcomes & Findings for Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1® (NCT NCT02341859)
NCT ID: NCT02341859
Last Updated: 2017-03-10
Results Overview
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline
Results posted on
2017-03-10
Participant Flow
Two participants enrolled in the study did not meet inclusion criteria. One participant was disqualified due to high power. All three participants therefore discontinued before lens randomization.
Participant milestones
| Measure |
Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A
Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A
Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
delefilcon A: contact lens
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
10
|
9
|
|
First Intervention (1 Day)
COMPLETED
|
10
|
9
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
10
|
9
|
|
Second Intervention (1 Day)
COMPLETED
|
10
|
9
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Baseline characteristics by cohort
| Measure |
Overall Participant Flow
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens
|
|---|---|
|
Age, Continuous
|
22 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselineConjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.13 units on a scale
Standard Deviation 0.23
|
0.16 units on a scale
Standard Deviation 0.24
|
0.21 units on a scale
Standard Deviation 0.30
|
0.21 units on a scale
Standard Deviation 0.30
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.39 units on a scale
Standard Deviation 0.43
|
0.34 units on a scale
Standard Deviation 0.50
|
0.34 units on a scale
Standard Deviation 0.37
|
0.45 units on a scale
Standard Deviation 0.44
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.26 units on a scale
Standard Deviation 0.26
|
0.18 units on a scale
Standard Deviation 0.34
|
0.24 units on a scale
Standard Deviation 0.35
|
0.34 units on a scale
Standard Deviation 0.37
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.42 units on a scale
Standard Deviation 0.48
|
0.53 units on a scale
Standard Deviation 0.51
|
0.68 units on a scale
Standard Deviation 0.53
|
0.47 units on a scale
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: 6 hoursConjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
1.11 units on a scale
Standard Deviation 0.74
|
0.47 units on a scale
Standard Deviation 0.46
|
1.39 units on a scale
Standard Deviation 0.89
|
0.97 units on a scale
Standard Deviation 0.68
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.26 units on a scale
Standard Deviation 0.45
|
0.24 units on a scale
Standard Deviation 0.31
|
0.45 units on a scale
Standard Deviation 0.60
|
0.61 units on a scale
Standard Deviation 1.04
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.53 units on a scale
Standard Deviation 0.56
|
0.63 units on a scale
Standard Deviation 0.60
|
0.87 units on a scale
Standard Deviation 0.60
|
1.24 units on a scale
Standard Deviation 1.03
|
|
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.97 units on a scale
Standard Deviation 0.49
|
0.79 units on a scale
Standard Deviation 0.54
|
1.00 units on a scale
Standard Deviation 0.75
|
1.29 units on a scale
Standard Deviation 0.87
|
PRIMARY outcome
Timeframe: BaselineConjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.08 units on a scale
Standard Deviation 0.34
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.08 units on a scale
Standard Deviation 0.34
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 6 hoursConjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.05 units on a scale
Standard Deviation 0.16
|
0.16 units on a scale
Standard Deviation 0.34
|
0.26 units on a scale
Standard Deviation 0.45
|
0.08 units on a scale
Standard Deviation 0.34
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.18 units on a scale
Standard Deviation 0.38
|
0.05 units on a scale
Standard Deviation 0.16
|
0.53 units on a scale
Standard Deviation 0.70
|
0.11 units on a scale
Standard Deviation 0.36
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.11 units on a scale
Standard Deviation 0.32
|
0.00 units on a scale
Standard Deviation 0.00
|
0.21 units on a scale
Standard Deviation 0.45
|
0.21 units on a scale
Standard Deviation 0.45
|
|
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.16 units on a scale
Standard Deviation 0.34
|
0.11 units on a scale
Standard Deviation 0.27
|
0.21 units on a scale
Standard Deviation 0.35
|
0.13 units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: BaselineLimbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.97 units on a scale
Standard Deviation 0.49
|
1.05 units on a scale
Standard Deviation 0.44
|
0.97 units on a scale
Standard Deviation 0.46
|
1.11 units on a scale
Standard Deviation 0.70
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.82 units on a scale
Standard Deviation 0.45
|
0.84 units on a scale
Standard Deviation 0.50
|
0.79 units on a scale
Standard Deviation 0.67
|
0.76 units on a scale
Standard Deviation 0.63
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.68 units on a scale
Standard Deviation 0.45
|
0.63 units on a scale
Standard Deviation 0.47
|
0.66 units on a scale
Standard Deviation 0.41
|
0.71 units on a scale
Standard Deviation 0.51
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.74 units on a scale
Standard Deviation 0.35
|
0.89 units on a scale
Standard Deviation 0.59
|
0.79 units on a scale
Standard Deviation 0.67
|
0.97 units on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: 6 hoursLimbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
1.08 units on a scale
Standard Deviation 0.63
|
1.03 units on a scale
Standard Deviation 0.35
|
1.05 units on a scale
Standard Deviation 0.50
|
1.34 units on a scale
Standard Deviation 0.76
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
1.00 units on a scale
Standard Deviation 0.44
|
1.03 units on a scale
Standard Deviation 0.49
|
1.16 units on a scale
Standard Deviation 0.55
|
1.13 units on a scale
Standard Deviation 0.64
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.89 units on a scale
Standard Deviation 0.52
|
0.84 units on a scale
Standard Deviation 0.44
|
0.84 units on a scale
Standard Deviation 0.55
|
0.84 units on a scale
Standard Deviation 0.50
|
|
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.89 units on a scale
Standard Deviation 0.49
|
0.84 units on a scale
Standard Deviation 0.41
|
0.95 units on a scale
Standard Deviation 0.64
|
0.95 units on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: BaselineCorneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.16 units on a scale
Standard Deviation 0.47
|
0.05 units on a scale
Standard Deviation 0.23
|
0.08 units on a scale
Standard Deviation 0.34
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.34 units on a scale
Standard Deviation 0.60
|
0.55 units on a scale
Standard Deviation 0.86
|
0.53 units on a scale
Standard Deviation 0.77
|
0.37 units on a scale
Standard Deviation 0.70
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.24 units on a scale
Standard Deviation 0.45
|
0.34 units on a scale
Standard Deviation 0.62
|
0.21 units on a scale
Standard Deviation 0.45
|
0.32 units on a scale
Standard Deviation 0.56
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.45 units on a scale
Standard Deviation 0.64
|
0.29 units on a scale
Standard Deviation 0.51
|
0.45 units on a scale
Standard Deviation 0.55
|
0.45 units on a scale
Standard Deviation 0.50
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.26 units on a scale
Standard Deviation 0.48
|
0.37 units on a scale
Standard Deviation 0.60
|
0.55 units on a scale
Standard Deviation 0.76
|
0.53 units on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 6 hoursCorneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.00 units on a scale
Standard Deviation 0.00
|
0.08 units on a scale
Standard Deviation 0.34
|
0.00 units on a scale
Standard Deviation 0.00
|
0.03 units on a scale
Standard Deviation 0.11
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.05 units on a scale
Standard Deviation 0.23
|
0.08 units on a scale
Standard Deviation 0.34
|
0.08 units on a scale
Standard Deviation 0.34
|
0.71 units on a scale
Standard Deviation 1.25
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.18 units on a scale
Standard Deviation 0.80
|
0.00 units on a scale
Standard Deviation 0.00
|
0.21 units on a scale
Standard Deviation 0.54
|
0.18 units on a scale
Standard Deviation 0.61
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.53 units on a scale
Standard Deviation 0.59
|
0.74 units on a scale
Standard Deviation 1.01
|
0.76 units on a scale
Standard Deviation 0.84
|
0.47 units on a scale
Standard Deviation 0.66
|
|
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.26 units on a scale
Standard Deviation 0.51
|
0.39 units on a scale
Standard Deviation 0.86
|
0.71 units on a scale
Standard Deviation 0.93
|
0.61 units on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: BaselineCorneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.24 units on a scale
Standard Deviation 0.51
|
0.34 units on a scale
Standard Deviation 0.53
|
0.32 units on a scale
Standard Deviation 0.53
|
0.24 units on a scale
Standard Deviation 0.45
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.13 units on a scale
Standard Deviation 0.23
|
0.18 units on a scale
Standard Deviation 0.42
|
0.18 units on a scale
Standard Deviation 0.42
|
0.24 units on a scale
Standard Deviation 0.42
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.18 units on a scale
Standard Deviation 0.25
|
0.16 units on a scale
Standard Deviation 0.29
|
0.24 units on a scale
Standard Deviation 0.31
|
0.32 units on a scale
Standard Deviation 0.42
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.24 units on a scale
Standard Deviation 0.45
|
0.32 units on a scale
Standard Deviation 0.71
|
0.37 units on a scale
Standard Deviation 0.55
|
0.34 units on a scale
Standard Deviation 0.47
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.13 units on a scale
Standard Deviation 0.47
|
0.03 units on a scale
Standard Deviation 0.11
|
0.03 units on a scale
Standard Deviation 0.11
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 6 hoursCorneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.00 units on a scale
Standard Deviation 0.00
|
0.03 units on a scale
Standard Deviation 0.11
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.11 units on a scale
Standard Deviation 0.46
|
0.03 units on a scale
Standard Deviation 0.11
|
0.03 units on a scale
Standard Deviation 0.11
|
0.24 units on a scale
Standard Deviation 0.39
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.18 units on a scale
Standard Deviation 0.34
|
0.16 units on a scale
Standard Deviation 0.29
|
0.37 units on a scale
Standard Deviation 0.52
|
0.39 units on a scale
Standard Deviation 0.43
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.03 units on a scale
Standard Deviation 0.11
|
0.00 units on a scale
Standard Deviation 0.00
|
0.09 units on a scale
Standard Deviation 0.19
|
0.11 units on a scale
Standard Deviation 0.32
|
|
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.29 units on a scale
Standard Deviation 0.30
|
0.29 units on a scale
Standard Deviation 0.30
|
0.37 units on a scale
Standard Deviation 0.37
|
0.29 units on a scale
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: BaselineCorneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.11 units on a scale
Standard Deviation 0.32
|
0.05 units on a scale
Standard Deviation 0.23
|
0.05 units on a scale
Standard Deviation 0.23
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.26 units on a scale
Standard Deviation 0.45
|
0.26 units on a scale
Standard Deviation 0.45
|
0.21 units on a scale
Standard Deviation 0.42
|
0.26 units on a scale
Standard Deviation 0.45
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.37 units on a scale
Standard Deviation 0.50
|
0.26 units on a scale
Standard Deviation 0.45
|
0.42 units on a scale
Standard Deviation 0.51
|
0.47 units on a scale
Standard Deviation 0.51
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.26 units on a scale
Standard Deviation 0.45
|
0.32 units on a scale
Standard Deviation 0.48
|
0.42 units on a scale
Standard Deviation 0.51
|
0.42 units on a scale
Standard Deviation 0.51
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.26 units on a scale
Standard Deviation 0.45
|
0.34 units on a scale
Standard Deviation 0.53
|
0.37 units on a scale
Standard Deviation 0.50
|
0.26 units on a scale
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: 6 hoursCorneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
C
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
N
|
0.05 units on a scale
Standard Deviation 0.23
|
0.05 units on a scale
Standard Deviation 0.33
|
0.05 units on a scale
Standard Deviation 0.23
|
0.32 units on a scale
Standard Deviation 0.48
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
T
|
0.05 units on a scale
Standard Deviation 0.23
|
0.00 units on a scale
Standard Deviation 0.00
|
0.16 units on a scale
Standard Deviation 0.37
|
0.11 units on a scale
Standard Deviation 0.32
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
S
|
0.53 units on a scale
Standard Deviation 0.51
|
0.55 units on a scale
Standard Deviation 0.69
|
0.58 units on a scale
Standard Deviation 0.51
|
0.42 units on a scale
Standard Deviation 0.51
|
|
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
I
|
0.26 units on a scale
Standard Deviation 0.45
|
0.26 units on a scale
Standard Deviation 0.45
|
0.47 units on a scale
Standard Deviation 0.51
|
0.53 units on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: 6 hoursCorneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
|
-0.007 mm
Standard Deviation 0.036
|
-0.004 mm
Standard Deviation 0.080
|
0.009 mm
Standard Deviation 0.035
|
0.017 mm
Standard Deviation 0.027
|
PRIMARY outcome
Timeframe: 6 hoursCorneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
|
0.004 microns
Standard Deviation 0.022
|
-0.006 microns
Standard Deviation 0.149
|
-0.006 microns
Standard Deviation 0.024
|
0.004 microns
Standard Deviation 0.019
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Yes
|
19 participants
|
19 participants
|
19 participants
|
19 participants
|
|
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
No
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Yes
|
19 participants
|
19 participants
|
19 participants
|
18 participants
|
|
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
No
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Temporal
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little temporal
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Centered
|
17 participants
|
19 participants
|
19 participants
|
13 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little loose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Loose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Temporal
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little temporal
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Centered
|
17 participants
|
18 participants
|
19 participants
|
14 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little loose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Loose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Up
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little Up
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Centered
|
15 participants
|
16 participants
|
17 participants
|
10 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little low
|
3 participants
|
3 participants
|
2 participants
|
6 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Low
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Centered
|
18 participants
|
18 participants
|
18 participants
|
10 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little low
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Up
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little Up
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Low
|
1 participants
|
0 participants
|
0 participants
|
6 participants
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Tight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little tight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
18 participants
|
18 participants
|
18 participants
|
19 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little loose
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Loose
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Loose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Tight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little tight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
17 participants
|
18 participants
|
18 participants
|
19 participants
|
|
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Little loose
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
12 participants
|
14 participants
|
16 participants
|
11 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Acceptable
|
6 participants
|
5 participants
|
3 participants
|
5 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
No lag
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Falls from cornea
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
16 participants
|
17 participants
|
17 participants
|
13 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Acceptable
|
3 participants
|
2 participants
|
2 participants
|
4 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
No lag
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Falls from cornea
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: BaselineLens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
15 participants
|
18 participants
|
18 participants
|
13 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Almost optimal
|
4 participants
|
1 participants
|
1 participants
|
5 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Border line to wear
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Not acceptable (cannot wear)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6 hoursLens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Optimal
|
18 participants
|
18 participants
|
19 participants
|
13 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Almost optimal
|
1 participants
|
1 participants
|
0 participants
|
4 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Border line to wear
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Not acceptable (cannot wear)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSubjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
None
|
18 participants
|
16 participants
|
12 participants
|
9 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Mild
|
1 participants
|
3 participants
|
5 participants
|
8 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Moderate
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Severe
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 hoursSubjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
None
|
15 participants
|
15 participants
|
13 participants
|
11 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Mild
|
2 participants
|
3 participants
|
6 participants
|
7 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Moderate
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSubjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
None
|
15 participants
|
17 participants
|
18 participants
|
16 participants
|
|
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Mild
|
4 participants
|
2 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 6 hoursSubjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
None
|
15 participants
|
16 participants
|
15 participants
|
14 participants
|
|
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Mild
|
4 participants
|
3 participants
|
3 participants
|
4 participants
|
|
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Moderate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 hoursSubjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
None
|
19 participants
|
19 participants
|
17 participants
|
16 participants
|
|
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Mild
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 3 hours, 6 hoursSubjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Baseline
|
91.3 units on a scale
Standard Deviation 13.7
|
92.5 units on a scale
Standard Deviation 14.2
|
93.0 units on a scale
Standard Deviation 8.1
|
90.2 units on a scale
Standard Deviation 11.5
|
|
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
3 hours
|
87.8 units on a scale
Standard Deviation 12.6
|
87.2 units on a scale
Standard Deviation 16.0
|
89.7 units on a scale
Standard Deviation 15.2
|
87.2 units on a scale
Standard Deviation 19.0
|
|
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
6 hours
|
88.7 units on a scale
Standard Deviation 15.1
|
88.6 units on a scale
Standard Deviation 14.9
|
85.4 units on a scale
Standard Deviation 16.5
|
84.6 units on a scale
Standard Deviation 120.3
|
SECONDARY outcome
Timeframe: Baseline, 3 hours, 6 hoursSubjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
6 hours
|
86.1 units on a scale
Standard Deviation 16.8
|
88.4 units on a scale
Standard Deviation 14.4
|
88.1 units on a scale
Standard Deviation 13.9
|
85.6 units on a scale
Standard Deviation 17.8
|
|
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Baseline
|
90.0 units on a scale
Standard Deviation 11.8
|
92.7 units on a scale
Standard Deviation 8.2
|
84.3 units on a scale
Standard Deviation 20.6
|
84.6 units on a scale
Standard Deviation 14.4
|
|
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
3 hours
|
90.0 units on a scale
Standard Deviation 16.3
|
88.4 units on a scale
Standard Deviation 17.2
|
90.2 units on a scale
Standard Deviation 12.5
|
86.1 units on a scale
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursSubjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Baseline (insertion)
|
95.8 units on a scale
Standard Deviation 5.3
|
93.0 units on a scale
Standard Deviation 9.4
|
90.9 units on a scale
Standard Deviation 10.8
|
91.3 units on a scale
Standard Deviation 12.8
|
|
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
6 hours (removal)
|
81.6 units on a scale
Standard Deviation 27.7
|
86.4 units on a scale
Standard Deviation 22.5
|
88.3 units on a scale
Standard Deviation 21.0
|
93.2 units on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline, 3 hours, 6 hoursSubjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Baseline
|
90.0 units on a scale
Standard Deviation 13.6
|
94.1 units on a scale
Standard Deviation 6.9
|
86.5 units on a scale
Standard Deviation 19.1
|
90.6 units on a scale
Standard Deviation 7.7
|
|
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
3 hours
|
93.5 units on a scale
Standard Deviation 11.4
|
96.8 units on a scale
Standard Deviation 3.9
|
93.2 units on a scale
Standard Deviation 10.0
|
90.3 units on a scale
Standard Deviation 13.0
|
|
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
6 hours
|
93.0 units on a scale
Standard Deviation 8.1
|
93.9 units on a scale
Standard Deviation 9.5
|
92.4 units on a scale
Standard Deviation 7.0
|
90.5 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 6 hoursSubjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
|
86.5 units on a scale
Standard Deviation 17.4
|
88.6 units on a scale
Standard Deviation 14.4
|
86.8 units on a scale
Standard Deviation 13.4
|
83.4 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.
Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)
Outcome measures
| Measure |
Stenfilcon A (Delefilcon A Group)
n=18 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A
n=18 Participants
Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Stenfilcon A (Narafilcon A Group)
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A
n=19 Participants
Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
|
|---|---|---|---|---|
|
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
|
7 participants
|
11 participants
|
15 participants
|
4 participants
|
Adverse Events
Stenfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delefilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Narafilcon 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
Taku Muraoka, OD, Director Professional Services Organization
Coopervision Japan
Phone: 81-3-5449-6619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER