Trial Outcomes & Findings for Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study (NCT NCT02637804)
NCT ID: NCT02637804
Last Updated: 2017-10-23
Results Overview
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
1 week
Results posted on
2017-10-23
Participant Flow
Participant milestones
| Measure |
Stenfilcon A, Then Narafilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A, Then Stenfilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A, Then Delefilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A, Then Stenfilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
|---|---|---|---|---|
|
First Intervention (1 Week)
STARTED
|
27
|
28
|
25
|
26
|
|
First Intervention (1 Week)
COMPLETED
|
27
|
28
|
25
|
26
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
27
|
28
|
25
|
26
|
|
Second Intervention (1 Week)
COMPLETED
|
27
|
28
|
25
|
26
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Baseline characteristics by cohort
| Measure |
Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11 • n=5 Participants
|
33 years
STANDARD_DEVIATION 11 • n=7 Participants
|
34 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
55 participants
n=5 Participants
|
51 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Pain and Foreign Body Sensation
No sensation
|
89 eyes
|
79 eyes
|
83 eyes
|
87 eyes
|
—
|
|
Pain and Foreign Body Sensation
Slight sensation
|
21 eyes
|
28 eyes
|
19 eyes
|
13 eyes
|
—
|
|
Pain and Foreign Body Sensation
Mild sensation
|
0 eyes
|
3 eyes
|
0 eyes
|
2 eyes
|
—
|
|
Pain and Foreign Body Sensation
Heavy sensation
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Itching Sensation on Removal
No sensation
|
98 Eyes
|
102 Eyes
|
92 Eyes
|
90 Eyes
|
—
|
|
Itching Sensation on Removal
Slight sensation
|
9 Eyes
|
8 Eyes
|
10 Eyes
|
10 Eyes
|
—
|
|
Itching Sensation on Removal
Mild sensation
|
3 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Itching Sensation on Removal
Heavy sensation
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
2 Eyes
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Red Eye Sensation
No sensation
|
98 Eyes
|
98 Eyes
|
92 Eyes
|
87 Eyes
|
—
|
|
Red Eye Sensation
Slight sensation
|
12 Eyes
|
10 Eyes
|
8 Eyes
|
15 Eyes
|
—
|
|
Red Eye Sensation
Mild sensation
|
0 Eyes
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
—
|
|
Red Eye Sensation
Heavy sensation
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Dryness
Right after insertion
|
9.56 units on a scale
Standard Deviation 1.14
|
9.40 units on a scale
Standard Deviation 1.36
|
9.84 units on a scale
Standard Deviation 0.50
|
9.76 units on a scale
Standard Deviation 0.90
|
—
|
|
Dryness
Right before removal
|
7.37 units on a scale
Standard Deviation 2.21
|
7.70 units on a scale
Standard Deviation 2.10
|
7.61 units on a scale
Standard Deviation 2.02
|
7.71 units on a scale
Standard Deviation 2.45
|
—
|
|
Dryness
All day long
|
8.08 units on a scale
Standard Deviation 1.89
|
8.36 units on a scale
Standard Deviation 1.74
|
8.27 units on a scale
Standard Deviation 1.66
|
8.40 units on a scale
Standard Deviation 1.92
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Comfort
Right after insertion
|
9.22 units on a scale
Standard Deviation 1.43
|
9.16 units on a scale
Standard Deviation 1.52
|
9.67 units on a scale
Standard Deviation 0.63
|
9.69 units on a scale
Standard Deviation 0.62
|
—
|
|
Comfort
Right before removal
|
8.00 units on a scale
Standard Deviation 1.85
|
8.17 units on a scale
Standard Deviation 2.00
|
8.43 units on a scale
Standard Deviation 2.02
|
8.29 units on a scale
Standard Deviation 1.94
|
—
|
|
Comfort
All day long
|
8.49 units on a scale
Standard Deviation 1.72
|
8.52 units on a scale
Standard Deviation 1.76
|
8.86 units on a scale
Standard Deviation 1.48
|
8.67 units on a scale
Standard Deviation 1.67
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Vision
Right after insertion
|
9.29 units on a scale
Standard Deviation 1.55
|
9.32 units on a scale
Standard Deviation 1.40
|
9.66 units on a scale
Standard Deviation 0.81
|
9.57 units on a scale
Standard Deviation 0.90
|
—
|
|
Vision
Right before removal
|
8.46 units on a scale
Standard Deviation 1.76
|
8.52 units on a scale
Standard Deviation 2.08
|
8.87 units on a scale
Standard Deviation 1.18
|
8.83 units on a scale
Standard Deviation 1.61
|
—
|
|
Vision
All day long
|
8.80 units on a scale
Standard Deviation 1.59
|
8.81 units on a scale
Standard Deviation 1.76
|
9.13 units on a scale
Standard Deviation 0.94
|
9.02 units on a scale
Standard Deviation 1.35
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Handling
Lens insertion
|
9.07 units on a scale
Standard Deviation 1.54
|
9.64 units on a scale
Standard Deviation 0.92
|
9.27 units on a scale
Standard Deviation 1.50
|
9.33 units on a scale
Standard Deviation 1.33
|
—
|
|
Handling
Lens removal
|
8.63 units on a scale
Standard Deviation 1.72
|
9.32 units on a scale
Standard Deviation 1.25
|
8.88 units on a scale
Standard Deviation 1.75
|
7.63 units on a scale
Standard Deviation 2.62
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=55 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
n=55 Participants
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
|
15 Participants
|
12 Participants
|
5 Participants
|
10 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=51 Participants
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
n=51 Participants
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
|
14 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: BaselineLens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Horizontal Centration
Temporal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Little Temporal
|
1 Eyes
|
6 Eyes
|
0 Eyes
|
2 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Central
|
109 Eyes
|
104 Eyes
|
102 Eyes
|
100 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Little Nasal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Nasal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekLens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Horizontal Centration
Temporal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Little Temporal
|
0 Eyes
|
8 Eyes
|
0 Eyes
|
1 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Central
|
110 Eyes
|
102 Eyes
|
102 Eyes
|
100 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Little Nasal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
1 Eyes
|
—
|
|
Lens Fit - Horizontal Centration
Nasal
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: BaselineLens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Vertical Centration
Upper
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Little Upper
|
2 Eyes
|
16 Eyes
|
0 Eyes
|
4 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Central
|
104 Eyes
|
86 Eyes
|
100 Eyes
|
96 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Little Lower
|
4 Eyes
|
8 Eyes
|
2 Eyes
|
2 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Lower
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekLens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Vertical Centration
Upper
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Little Upper
|
0 Eyes
|
7 Eyes
|
0 Eyes
|
4 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Central
|
107 Eyes
|
90 Eyes
|
102 Eyes
|
98 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Little Lower
|
3 Eyes
|
13 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Vertical Centration
Lower
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: BaselineLens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Post-blink Movement
Tight
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Little Tight
|
0 Eyes
|
6 Eyes
|
2 Eyes
|
4 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Optimum
|
104 Eyes
|
94 Eyes
|
96 Eyes
|
97 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Little Loose
|
6 Eyes
|
10 Eyes
|
4 Eyes
|
1 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Loose
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekLens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit - Post-blink Movement
Tight
|
0 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Little Tight
|
0 Eyes
|
10 Eyes
|
1 Eyes
|
5 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Optimum
|
107 Eyes
|
92 Eyes
|
97 Eyes
|
97 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Little Loose
|
3 Eyes
|
5 Eyes
|
4 Eyes
|
0 Eyes
|
—
|
|
Lens Fit - Post-blink Movement
Loose
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: BaselineLens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit Overall
Good
|
10 Eyes
|
26 Eyes
|
4 Eyes
|
12 Eyes
|
—
|
|
Lens Fit Overall
Acceptable
|
0 Eyes
|
3 Eyes
|
2 Eyes
|
0 Eyes
|
—
|
|
Lens Fit Overall
Optimum
|
100 Eyes
|
81 Eyes
|
96 Eyes
|
90 Eyes
|
—
|
|
Lens Fit Overall
Not Acceptable
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekLens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Lens Fit Overall
Good
|
8 Eyes
|
30 Eyes
|
2 Eyes
|
7 Eyes
|
—
|
|
Lens Fit Overall
Acceptable
|
0 Eyes
|
3 Eyes
|
2 Eyes
|
0 Eyes
|
—
|
|
Lens Fit Overall
Not Acceptable
|
0 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Lens Fit Overall
Optimum
|
102 Eyes
|
75 Eyes
|
98 Eyes
|
95 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekConjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Conjunctival Redness
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Conjunctival Redness
Normal
|
104 Eyes
|
99 Eyes
|
100 Eyes
|
100 Eyes
|
—
|
|
Conjunctival Redness
Trace
|
6 Eyes
|
11 Eyes
|
2 Eyes
|
2 Eyes
|
—
|
|
Conjunctival Redness
Mild
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Conjunctival Redness
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekLimbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Limbal Redness
Trace
|
0 Eyes
|
4 Eyes
|
0 Eyes
|
3 Eyes
|
—
|
|
Limbal Redness
Mild
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Limbal Redness
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Limbal Redness
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Limbal Redness
Normal
|
110 Eyes
|
106 Eyes
|
102 Eyes
|
99 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekCorneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Corneal Staining
Normal
|
83 Eyes
|
69 Eyes
|
71 Eyes
|
70 Eyes
|
—
|
|
Corneal Staining
Trace
|
25 Eyes
|
39 Eyes
|
31 Eyes
|
29 Eyes
|
—
|
|
Corneal Staining
Mild
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
3 Eyes
|
—
|
|
Corneal Staining
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Staining
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekCorneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Corneal Neovascularization
Normal
|
108 Eyes
|
108 Eyes
|
102 Eyes
|
102 Eyes
|
—
|
|
Corneal Neovascularization
Trace
|
2 Eyes
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Neovascularization
Mild
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Neovascularization
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Neovascularization
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekConjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Conjunctival Staining
Normal
|
75 Eyes
|
67 Eyes
|
76 Eyes
|
80 Eyes
|
—
|
|
Conjunctival Staining
Trace
|
28 Eyes
|
29 Eyes
|
22 Eyes
|
16 Eyes
|
—
|
|
Conjunctival Staining
Mild
|
7 Eyes
|
14 Eyes
|
4 Eyes
|
6 Eyes
|
—
|
|
Conjunctival Staining
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Conjunctival Staining
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekCorneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Corneal Oedema
Trace
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Oedema
Mild
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Oedema
Normal
|
110 Eyes
|
110 Eyes
|
102 Eyes
|
102 Eyes
|
—
|
|
Corneal Oedema
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Corneal Oedema
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: 1 weekPapillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Outcome measures
| Measure |
Stenfilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Narafilcon A (Group 1)
n=110 Eyes
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
|
Stenfilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Delefilcon A (Group 2)
n=102 Eyes
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens
|
Prefer Narafilcon A
narafilcon A: contact lens
|
|---|---|---|---|---|---|
|
Papillary Conjunctivitis
Severe
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Papillary Conjunctivitis
Normal
|
110 Eyes
|
110 Eyes
|
102 Eyes
|
102 Eyes
|
—
|
|
Papillary Conjunctivitis
Trace
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Papillary Conjunctivitis
Mild
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
|
Papillary Conjunctivitis
Moderate
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
—
|
Adverse Events
Stenfilcon A (Group 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Narafilcon A (Group1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stenfilcon A (Group 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delefilcon A (Group 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER