Trial Outcomes & Findings for Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers (NCT NCT04668989)
NCT ID: NCT04668989
Last Updated: 2021-09-16
Results Overview
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
COMPLETED
NA
68 participants
Baseline - after 2 hours of lens wear
2021-09-16
Participant Flow
68 participants were screened, 2 subjects discontinued, and 66 subjects were dispensed with the study lenses.
Participant milestones
| Measure |
Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens)
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)
kalifilcon A - (Control lens)
|
Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens)
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
stenfilcon A - (Test lens)
kalifilcon A - (Control Lens)
|
|---|---|---|
|
First Intervention
STARTED
|
36
|
30
|
|
First Intervention
COMPLETED
|
36
|
29
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
36
|
29
|
|
Second Intervention
COMPLETED
|
36
|
28
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens)
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)
kalifilcon A - (Control lens)
|
Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens)
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
stenfilcon A - (Test lens)
kalifilcon A - (Control Lens)
|
|---|---|---|
|
First Intervention
Covid-19 related self-isolation
|
0
|
1
|
|
Second Intervention
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=68 Participants
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)
kalifilcon A - (Control Lens)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 8.2 • n=68 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Baseline - after 2 hours of lens wearLens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Outcome measures
| Measure |
Stenfilcon A - (Test Lens)
n=64 Participants
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)
|
Kalifilcon A - (Control Lens)
n=64 Participants
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
kalifilcon A - (Control lens)
|
|---|---|---|
|
Lens Wettability
|
3.7 units on a scale
Standard Deviation 0.4
|
3.7 units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 1 weekLens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Outcome measures
| Measure |
Stenfilcon A - (Test Lens)
n=64 Participants
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)
|
Kalifilcon A - (Control Lens)
n=64 Participants
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
kalifilcon A - (Control lens)
|
|---|---|---|
|
Lens Wettability
|
3.5 units on a scale
Standard Deviation 0.6
|
3.5 units on a scale
Standard Deviation 0.6
|
Adverse Events
Stenfilcon A - (Test Lens)
Kalifilcon A - (Control Lens)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stenfilcon A - (Test Lens)
n=66 participants at risk
Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
|
Kalifilcon A - (Control Lens)
n=66 participants at risk
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
|
|---|---|---|
|
Eye disorders
Corneal Abrasion
|
1.5%
1/66 • Number of events 1 • From dispense up to 1 week on each study lens, a total of 2 weeks
|
0.00%
0/66 • From dispense up to 1 week on each study lens, a total of 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place