Trial Outcomes & Findings for Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens (NCT NCT03024970)
NCT ID: NCT03024970
Last Updated: 2020-07-21
Results Overview
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Baseline
Results posted on
2020-07-21
Participant Flow
Participant milestones
| Measure |
Test Lens Then Control Lens
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): contact lens stenfilcon A lens (Control): contact lens
|
Control Lens Then Test Lens
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens stenfilcon A lens with solution additive (test): contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
34
|
38
|
|
First Intervention
COMPLETED
|
33
|
38
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
33
|
38
|
|
Second Intervention
COMPLETED
|
32
|
38
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test Lens Then Control Lens
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): contact lens stenfilcon A lens (Control): contact lens
|
Control Lens Then Test Lens
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens stenfilcon A lens with solution additive (test): contact lens
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
Second Intervention
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=72 Participants
Total Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=72 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 7 • n=72 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=72 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=72 Participants
|
PRIMARY outcome
Timeframe: BaselineSubjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Comfort
|
9.7 units on a scale
Standard Deviation 0.6
|
9.6 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 1 WeekSubjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Comfort
|
9.1 units on a scale
Standard Deviation 1.5
|
9.0 units on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 1 MonthSubjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Comfort
|
8.9 units on a scale
Standard Deviation 1.7
|
8.6 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: BaselineSubjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Vision Satisfaction
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Vision Satisfaction
Disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Vision Satisfaction
Neutral
|
6 percentage of participants
|
1 percentage of participants
|
|
Vision Satisfaction
Agree
|
39 percentage of participants
|
39 percentage of participants
|
|
Vision Satisfaction
Strongly agree
|
55 percentage of participants
|
60 percentage of participants
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Vision Satisfaction
Strongly disagree
|
0 percentage of participants
|
1 percentage of participants
|
|
Vision Satisfaction
Disagree
|
3 percentage of participants
|
1 percentage of participants
|
|
Vision Satisfaction
Neutral
|
3 percentage of participants
|
4 percentage of participants
|
|
Vision Satisfaction
Agree
|
29 percentage of participants
|
26 percentage of participants
|
|
Vision Satisfaction
Strongly agree
|
65 percentage of participants
|
68 percentage of participants
|
PRIMARY outcome
Timeframe: 1 MonthSubjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Vision Satisfaction
Strongly disagree
|
3 percentage of participants
|
1 percentage of participants
|
|
Vision Satisfaction
Disagree
|
1 percentage of participants
|
3 percentage of participants
|
|
Vision Satisfaction
Neutral
|
4 percentage of participants
|
9 percentage of participants
|
|
Vision Satisfaction
Agree
|
34 percentage of participants
|
26 percentage of participants
|
|
Vision Satisfaction
Strongly agree
|
58 percentage of participants
|
61 percentage of participants
|
PRIMARY outcome
Timeframe: BaselineVisual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On High Illumination High Contrast
|
-0.20 LogMAR
Standard Deviation 0.06
|
-0.21 LogMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 1 WeekVisual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On High Illumination High Contrast
|
-0.21 LogMAR
Standard Deviation 0.06
|
-0.20 LogMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 1 MonthVisual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On High Illumination High Contrast
|
-0.21 LogMAR
Standard Deviation 0.07
|
-0.20 LogMAR
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: BaselineVisual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On Low Illumination High Contrast
|
-0.08 LogMAR
Standard Deviation 0.09
|
-0.09 LogMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 1 WeekVisual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On Low Illumination High Contrast
|
-0.09 LogMAR
Standard Deviation 0.10
|
-0.09 LogMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 1 MonthVisual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Visual Acuity On Low Illumination High Contrast
|
-0.09 LogMAR
Standard Deviation 0.10
|
-0.09 LogMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: One WeekOverall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Overall Corneal Staining
Grade 0
|
55 percentage of participants
|
57 percentage of participants
|
|
Overall Corneal Staining
Garde 1
|
31 percentage of participants
|
27 percentage of participants
|
|
Overall Corneal Staining
Grade 2
|
14 percentage of participants
|
14 percentage of participants
|
|
Overall Corneal Staining
Grade 3
|
0 percentage of participants
|
2 percentage of participants
|
|
Overall Corneal Staining
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: One MonthOverall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Overall Corneal Staining
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
|
Overall Corneal Staining
Grade 0
|
54 percentage of participants
|
58 percentage of participants
|
|
Overall Corneal Staining
Garde 1
|
33 percentage of participants
|
30 percentage of participants
|
|
Overall Corneal Staining
Grade 2
|
13 percentage of participants
|
11 percentage of participants
|
|
Overall Corneal Staining
Grade 3
|
0 percentage of participants
|
1 percentage of participants
|
PRIMARY outcome
Timeframe: 1 WeekConjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Conjunctival Staining
|
0.36 units on a scale
Standard Deviation 0.45
|
0.39 units on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 1 MonthConjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Conjunctival Staining
|
0.42 units on a scale
Standard Deviation 0.37
|
0.45 units on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 1 WeekBulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Bulbar Hyperemia
|
1.32 units on a scale
Standard Deviation 0.85
|
1.28 units on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: 1 MonthBulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Bulbar Hyperemia
|
1.36 units on a scale
Standard Deviation 0.81
|
1.33 units on a scale
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: 1 WeekLimbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Limbal Hyperemia
|
0.85 units on a scale
Standard Deviation 0.64
|
0.89 units on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 1 MonthLimbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Limbal Hyperemia
|
0.90 units on a scale
Standard Deviation 0.66
|
0.78 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: 1 WeekPalpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Palpebral Hyperemia
|
0.89 units on a scale
Standard Deviation 0.65
|
0.88 units on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 1 MonthPalpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Palpebral Hyperemia
|
1.02 units on a scale
Standard Deviation 0.63
|
0.93 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: BaselineOverall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Fit Acceptance
|
3.4 units on a scale
Standard Deviation 0.3
|
3.3 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 1 weekOverall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Fit Acceptance
|
3.3 units on a scale
Standard Deviation 0.3
|
3.3 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 1 MonthOverall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Fit Acceptance
|
3.3 units on a scale
Standard Deviation 0.3
|
3.2 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 weekHandling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Handling Satisfaction
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Handling Satisfaction
Disagree
|
0 percentage of participants
|
1 percentage of participants
|
|
Handling Satisfaction
Neutral
|
3 percentage of participants
|
1 percentage of participants
|
|
Handling Satisfaction
Agree
|
25 percentage of participants
|
23 percentage of participants
|
|
Handling Satisfaction
Strongly Agree
|
72 percentage of participants
|
75 percentage of participants
|
SECONDARY outcome
Timeframe: 1 MonthHandling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Handling Satisfaction
Strongly disagree
|
0 percentage of participants
|
1 percentage of participants
|
|
Handling Satisfaction
Disagree
|
0 percentage of participants
|
4 percentage of participants
|
|
Handling Satisfaction
Neutral
|
1 percentage of participants
|
0 percentage of participants
|
|
Handling Satisfaction
Agree
|
30 percentage of participants
|
23 percentage of participants
|
|
Handling Satisfaction
Strongly Agree
|
69 percentage of participants
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: BaselineWettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Wettability
|
3.52 units on a scale
Standard Deviation 0.36
|
3.52 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 1 WeekWettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Wettability
|
3.47 units on a scale
Standard Deviation 0.46
|
3.33 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 1 MonthWettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Wettability
|
3.37 units on a scale
Standard Deviation 0.43
|
3.38 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: BaselineDeposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Deposits
|
0.03 units on a scale
Standard Deviation 0.15
|
0.02 units on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 1 weekDeposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Deposits
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 1 MonthDeposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=140 Eyes
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=140 Eyes
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Lens Surface - Deposits
|
0.06 units on a scale
Standard Deviation 0.27
|
0.02 units on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: BaselineSubjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Dryness
|
9.6 units on a scale
Standard Deviation 1.3
|
9.5 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 1 weekSubjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Dryness
|
8.8 units on a scale
Standard Deviation 1.8
|
8.8 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 1 MonthSubjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Outcome measures
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=70 Participants
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=70 Participants
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Subjective Ratings on Dryness
|
8.3 units on a scale
Standard Deviation 2.1
|
8.1 units on a scale
Standard Deviation 2.3
|
Adverse Events
Stenfilcon A Lens With Solution Additive (Test)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stenfilcon A Lens (Control)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stenfilcon A Lens With Solution Additive (Test)
n=72 participants at risk
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens with solution additive (test): silicone hydrogel lens
|
Stenfilcon A Lens (Control)
n=72 participants at risk
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
stenfilcon A lens (control): contact lens
|
|---|---|---|
|
Eye disorders
Corneal Staining
|
1.4%
1/72 • Number of events 1 • From baseline up to 1 month on each pair of lenses.
|
2.8%
2/72 • Number of events 2 • From baseline up to 1 month on each pair of lenses.
|
|
Eye disorders
Subconjuctival Hyperemia
|
0.00%
0/72 • From baseline up to 1 month on each pair of lenses.
|
2.8%
2/72 • Number of events 2 • From baseline up to 1 month on each pair of lenses.
|
|
Eye disorders
Epithelial defect
|
0.00%
0/72 • From baseline up to 1 month on each pair of lenses.
|
1.4%
1/72 • Number of events 1 • From baseline up to 1 month on each pair of lenses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place