Trial Outcomes & Findings for A Clinical Comparison of Two Daily Disposable Soft Contact Lenses (NCT NCT04005885)
NCT ID: NCT04005885
Last Updated: 2021-01-05
Results Overview
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-01-05
Participant Flow
All subjects were fitted with comfilcon A for one month and then the subjects were randomized to wear two daily disposable lenses for one week.
Participant milestones
| Measure |
Somofilcon A, Then Stenfilcon A Contact Lens
All subjects fitted with the comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear the somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A : contact lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens
|
Stenfilcon A, Then Somofilcon A Contact Lens
All subjects fitted with comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A: Contact Lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
26
|
29
|
|
First Intervention
COMPLETED
|
25
|
28
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
25
|
28
|
|
Second Intervention
COMPLETED
|
25
|
26
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
|
Third Intervention
STARTED
|
25
|
26
|
|
Third Intervention
COMPLETED
|
25
|
26
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Somofilcon A, Then Stenfilcon A Contact Lens
All subjects fitted with the comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear the somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A : contact lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens
|
Stenfilcon A, Then Somofilcon A Contact Lens
All subjects fitted with comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
comfilcon A: Contact Lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
|
Second Intervention
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=55 Participants
Subjects were randomized to wear comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens and stenfilcon A daily disposable test lens each for 1 week of daily wear.
comfilcon A: Contact Lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=55 Participants
|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 5.7 • n=55 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=55 Participants
|
|
Region of Enrollment
United Kingdom
|
55 participants
n=55 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing visit.
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
|
89.9 units on a scale
Standard Deviation 14.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 weekSubjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores of Comfort on Insertion
|
90.3 units on a scale
Standard Deviation 12.6
|
90.4 units on a scale
Standard Deviation 12.8
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One Subject discontinued after dispensing visit
Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
|
83.7 units on a scale
Standard Deviation 15.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekSubjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores on Overall Comfort
|
84.0 units on a scale
Standard Deviation 16.8
|
85.7 units on a scale
Standard Deviation 13.2
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One Subject discontinued after dispensing visit
Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
|
73.1 units on a scale
Standard Deviation 20.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekSubjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Subjective Scores on Comfort Before Removal
|
77.6 units on a scale
Standard Deviation 19.0
|
79.3 units on a scale
Standard Deviation 15.8
|
—
|
SECONDARY outcome
Timeframe: Baseline (after 5 minutes of lens dispense)Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=51 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
n=53 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Horizontal Lens Centration Grade
Extremely nasal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Horizontal Lens Centration Grade
Slightly nasal
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Horizontal Lens Centration Grade
Optimum
|
35 Participants
|
19 Participants
|
33 Participants
|
|
Number of Participants With Horizontal Lens Centration Grade
Slightly Temporal
|
20 Participants
|
30 Participants
|
18 Participants
|
|
Number of Participants With Horizontal Lens Centration Grade
Extremely Temporal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing visit
Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Extremely nasal
|
0 Participants
|
—
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Slightly nasal
|
1 Participants
|
—
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Optimum
|
32 Participants
|
—
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Slightly Temporal
|
21 Participants
|
—
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Extremely Temporal
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Horizontal Lens Centration Grade
Extremely nasal
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade
Slightly nasal
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade
Optimum
|
20 Participants
|
30 Participants
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade
Slightly Temporal
|
28 Participants
|
21 Participants
|
—
|
|
Number of Participants With Horizontal Lens Centration Grade
Extremely Temporal
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (After 5 minutes of lens dispense)Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=51 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
n=53 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Vertical Lens Centration Grade
Extremely Inferior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vertical Lens Centration Grade
Slightly Inferior
|
12 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Vertical Lens Centration Grade
Optimum
|
35 Participants
|
23 Participants
|
35 Participants
|
|
Number of Participants With Vertical Lens Centration Grade
Slightly Superior
|
8 Participants
|
20 Participants
|
11 Participants
|
|
Number of Participants With Vertical Lens Centration Grade
Extremely Superior
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing visit
Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Extremely Inferior
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Slightly Inferior
|
9 Participants
|
—
|
—
|
|
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Optimum
|
38 Participants
|
—
|
—
|
|
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Slightly Superior
|
7 Participants
|
—
|
—
|
|
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Extremely Superior
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Vertical Lens Centration Grade
Optimum
|
22 Participants
|
37 Participants
|
—
|
|
Number of Participants With Vertical Lens Centration Grade
Extremely Inferior
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vertical Lens Centration Grade
Slightly Inferior
|
10 Participants
|
4 Participants
|
—
|
|
Number of Participants With Vertical Lens Centration Grade
Slightly Superior
|
19 Participants
|
11 Participants
|
—
|
|
Number of Participants With Vertical Lens Centration Grade
Extremely Superior
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (after 5 minutes of lens dispense)Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=51 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
n=53 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Lens Corneal Coverage Grade
Extremely Inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Lens Corneal Coverage Grade
Slightly inadequate
|
3 Participants
|
23 Participants
|
1 Participants
|
|
Number of Participants With Lens Corneal Coverage Grade
Optimum
|
48 Participants
|
26 Participants
|
46 Participants
|
|
Number of Participants With Lens Corneal Coverage Grade
Slightly excessive
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Lens Corneal Coverage Grade
Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing Visit
Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Extremely Inadequate
|
0 Participants
|
—
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Slightly inadequate
|
4 Participants
|
—
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Optimum
|
43 Participants
|
—
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Slightly excessive
|
6 Participants
|
—
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Extremely excessive
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Lens Corneal Coverage Grade
Extremely Inadequate
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade
Slightly inadequate
|
20 Participants
|
3 Participants
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade
Optimum
|
30 Participants
|
43 Participants
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade
Slightly excessive
|
1 Participants
|
6 Participants
|
—
|
|
Number of Participants With Lens Corneal Coverage Grade
Extremely excessive
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (after 5 minutes of lens dispense)Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=51 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
n=53 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Post-Blink Movement Grade
Extremely inadequate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Blink Movement Grade
Slightly inadequate
|
11 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Post-Blink Movement Grade
Optimum
|
35 Participants
|
33 Participants
|
31 Participants
|
|
Number of Participants With Post-Blink Movement Grade
Slightly excessive
|
9 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants With Post-Blink Movement Grade
Extremely excessive
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing visit
Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Extremely inadequate
|
0 Participants
|
—
|
—
|
|
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Slightly inadequate
|
6 Participants
|
—
|
—
|
|
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Optimum
|
38 Participants
|
—
|
—
|
|
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Slightly excessive
|
10 Participants
|
—
|
—
|
|
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Extremely excessive
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Number of Participants With Post-Blink Movement Grade
Extremely inadequate
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Post-Blink Movement Grade
Slightly inadequate
|
5 Participants
|
5 Participants
|
—
|
|
Number of Participants With Post-Blink Movement Grade
Optimum
|
34 Participants
|
28 Participants
|
—
|
|
Number of Participants With Post-Blink Movement Grade
Slightly excessive
|
12 Participants
|
19 Participants
|
—
|
|
Number of Participants With Post-Blink Movement Grade
Extremely excessive
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (after 5 minutes of lens dispense)Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=51 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
n=53 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Investigator Lens Fit Acceptance
Acceptable Fits
|
100 percentage of lenses
|
100 percentage of lenses
|
100 percentage of lenses
|
|
Investigator Lens Fit Acceptance
Optimum Fits
|
27 percentage of lenses
|
16 percentage of lenses
|
28 percentage of lenses
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One subject discontinued after dispensing visit
Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Acceptable Fits
|
98 percentage of lenses
|
—
|
—
|
|
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Optimum Fits
|
33 percentage of lenses
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekLens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Outcome measures
| Measure |
Comfilcon A
n=51 Participants
Participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month.
comfilcon A: Contact Lens
|
Stenfilcon A Contact Lens
n=52 Participants
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
Stenfilcon A Contact Lens
Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear.
stenfilcon A: daily disposable contact lens
|
|---|---|---|---|
|
Investigator Lens Fit Acceptance
Acceptable Fits
|
100 percentage of lenses
|
100 percentage of lenses
|
—
|
|
Investigator Lens Fit Acceptance
Optimum Fits
|
10 percentage of lenses
|
21 percentage of lenses
|
—
|
Adverse Events
Comfilcon A Contact Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Somofilcon A Contact Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stenfilcon A Contact Lens
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