Trial Outcomes & Findings for Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses (NCT NCT04305912)
NCT ID: NCT04305912
Last Updated: 2022-02-14
Results Overview
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
1 week
Results posted on
2022-02-14
Participant Flow
Participant milestones
| Measure |
Somofilcon A Then Verofilcon A
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.
|
Verofilcon A the Somofilcon A
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
First Intervention
STARTED
|
26
|
25
|
|
First Intervention
COMPLETED
|
24
|
24
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Second Intervention
STARTED
|
24
|
24
|
|
Second Intervention
COMPLETED
|
24
|
23
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Somofilcon A Then Verofilcon A
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.
|
Verofilcon A the Somofilcon A
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
First Intervention
COVID-19 Suspension
|
2
|
0
|
|
First Intervention
Withdrawal by Subject
|
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=51 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses and verofilcon A daily disposable lenses for one week.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 12.3 • n=51 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=51 Participants
|
|
Region of Enrollment
Canada
|
51 participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Subjective Ratings for Lens Handling for Lens Insertion
|
9.3 units on a scale
Standard Deviation 0.9
|
9.2 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Subjective Ratings for Lens Handling for Lens Removal
|
9.1 units on a scale
Standard Deviation 1.3
|
8.8 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: BaselineLens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive \& occasionally encroaching limbus)
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Centration
|
0.7 units on a scale
Standard Deviation 0.7
|
0.4 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1-weekPopulation: One subject missed follow-up assessment for lens-fit centration.
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive \& occasionally encroaching limbus)
Outcome measures
| Measure |
Somofilcon A
n=46 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=46 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Centration
|
0.5 units on a scale
Standard Deviation 0.6
|
0.3 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: BaselinePost-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Post-blink Movement
|
0.2 mm
Standard Deviation 0.1
|
0.2 mm
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 1-weekPost-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Post-blink Movement
|
0.2 mm
Standard Deviation 0.1
|
0.2 mm
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: BaselineThe lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Lens Push-up Tightness
|
50 units on a scale
Standard Deviation 4
|
49 units on a scale
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 1-weekThe lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Outcome measures
| Measure |
Somofilcon A
n=47 Participants
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=47 Participants
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Lens Fit - Lens Push-up Tightness
|
51 units on a scale
Standard Deviation 5
|
51 units on a scale
Standard Deviation 5
|
Adverse Events
Somofilcon A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Verofilcon A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Somofilcon A
n=51 participants at risk
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
|
Verofilcon A
n=51 participants at risk
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperemia
|
2.0%
1/51 • Number of events 1 • From dispense to 1 week on each lens, a total of two weeks.
|
0.00%
0/51 • From dispense to 1 week on each lens, a total of two weeks.
|
|
Eye disorders
Mild Ocular Redness
|
2.0%
1/51 • Number of events 1 • From dispense to 1 week on each lens, a total of two weeks.
|
0.00%
0/51 • From dispense to 1 week on each lens, a total of two weeks.
|
|
Eye disorders
Headache
|
0.00%
0/51 • From dispense to 1 week on each lens, a total of two weeks.
|
2.0%
1/51 • Number of events 1 • From dispense to 1 week on each lens, a total of two weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place