Trial Outcomes & Findings for Comparison of Two Daily Disposable Soft Contact Lenses (NCT NCT03779503)
NCT ID: NCT03779503
Last Updated: 2020-10-08
Results Overview
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Baseline
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
Midafilcon A Then Somofilcon A
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens
|
Somofilcon A Then Midafilcon A
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
28
|
27
|
|
First Intervention
COMPLETED
|
27
|
26
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
27
|
26
|
|
Second Intervention
COMPLETED
|
27
|
26
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Midafilcon A Then Somofilcon A
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens
|
Somofilcon A Then Midafilcon A
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
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 either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day 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
|
26.3 years
STANDARD_DEVIATION 6.3 • n=55 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=55 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
PRIMARY outcome
Timeframe: BaselineAssessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Outcome measures
| Measure |
Midafilcon A
n=54 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=54 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Horizontal Centration
Extremely nasal
|
0 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Horizontal Centration
Slightly nasal
|
6 percentage of lenses
|
4 percentage of lenses
|
|
Lens Fit - Horizontal Centration
Optimum
|
61 percentage of lenses
|
48 percentage of lenses
|
|
Lens Fit - Horizontal Centration
Slightly Temporal
|
33 percentage of lenses
|
48 percentage of lenses
|
|
Lens Fit - Horizontal Centration
Extremely Temporal
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: One WeekAssessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Outcome measures
| Measure |
Midafilcon A
n=53 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=53 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Horizontal Centration
Extremely nasal
|
0 participants of lenses
|
0 participants of lenses
|
|
Lens Fit - Horizontal Centration
Slightly nasal
|
8 participants of lenses
|
6 participants of lenses
|
|
Lens Fit - Horizontal Centration
Optimum
|
60 participants of lenses
|
55 participants of lenses
|
|
Lens Fit - Horizontal Centration
Slightly Temporal
|
32 participants of lenses
|
40 participants of lenses
|
|
Lens Fit - Horizontal Centration
Extremely Temporal
|
0 participants of lenses
|
0 participants of lenses
|
PRIMARY outcome
Timeframe: BaselineAssessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Outcome measures
| Measure |
Midafilcon A
n=54 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=54 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Vertical Centration
Extremely inferior
|
0 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Vertical Centration
Slightly inferior
|
31 percentage of lenses
|
22 percentage of lenses
|
|
Lens Fit - Vertical Centration
Optimum
|
54 percentage of lenses
|
46 percentage of lenses
|
|
Lens Fit - Vertical Centration
Slightly Superior
|
15 percentage of lenses
|
31 percentage of lenses
|
|
Lens Fit - Vertical Centration
Extremely Superior
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: One WeekAssessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Outcome measures
| Measure |
Midafilcon A
n=53 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=53 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Vertical Centration
Extremely inferior
|
2 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Vertical Centration
Slightly inferior
|
32 percentage of lenses
|
26 percentage of lenses
|
|
Lens Fit - Vertical Centration
Optimum
|
47 percentage of lenses
|
43 percentage of lenses
|
|
Lens Fit - Vertical Centration
Slightly Superior
|
19 percentage of lenses
|
30 percentage of lenses
|
|
Lens Fit - Vertical Centration
Extremely Superior
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: BaselineAssessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Outcome measures
| Measure |
Midafilcon A
n=54 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=54 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Corneal Coverage
Extremely inadequate
|
0 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Slightly inadequate
|
17 percentage of lenses
|
22 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Optimum
|
76 percentage of lenses
|
70 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Slightly excessive
|
7 percentage of lenses
|
7 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Extremely excessive
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: One WeekAssessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Outcome measures
| Measure |
Midafilcon A
n=53 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=53 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Corneal Coverage
Extremely inadequate
|
2 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Slightly inadequate
|
19 percentage of lenses
|
34 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Optimum
|
72 percentage of lenses
|
60 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Slightly excessive
|
8 percentage of lenses
|
6 percentage of lenses
|
|
Lens Fit - Corneal Coverage
Extremely excessive
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: BaselineLens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Outcome measures
| Measure |
Midafilcon A
n=54 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=54 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Lens Movement
Extremely inadequate
|
0 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Lens Movement
Slightly inadequate
|
11 percentage of lenses
|
9 percentage of lenses
|
|
Lens Fit - Lens Movement
Optimum
|
56 percentage of lenses
|
79 percentage of lenses
|
|
Lens Fit - Lens Movement
Slightly excessive
|
33 percentage of lenses
|
13 percentage of lenses
|
|
Lens Fit - Lens Movement
Extremely excessive
|
0 percentage of lenses
|
0 percentage of lenses
|
PRIMARY outcome
Timeframe: One WeekLens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Outcome measures
| Measure |
Midafilcon A
n=53 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=53 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Lens Fit - Lens Movement
Extremely inadequate
|
0 percentage of lenses
|
0 percentage of lenses
|
|
Lens Fit - Lens Movement
Slightly inadequate
|
13 percentage of lenses
|
11 percentage of lenses
|
|
Lens Fit - Lens Movement
Optimum
|
55 percentage of lenses
|
75 percentage of lenses
|
|
Lens Fit - Lens Movement
Slightly excessive
|
30 percentage of lenses
|
13 percentage of lenses
|
|
Lens Fit - Lens Movement
Extremely excessive
|
2 percentage of lenses
|
0 percentage of lenses
|
SECONDARY outcome
Timeframe: BaselineSubjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Outcome measures
| Measure |
Midafilcon A
n=54 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=54 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Subjective Score for Vision
|
93.1 units on a scale
Standard Deviation 8.5
|
95.0 units on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: One weekSubjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Outcome measures
| Measure |
Midafilcon A
n=53 Participants
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens
|
Somofilcon A
n=53 Participants
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
somofilcon A: somofilcon A 1 day daily disposable contact lens
|
|---|---|---|
|
Subjective Score for Vision
|
86.5 units on a scale
Standard Deviation 15.5
|
91.7 units on a scale
Standard Deviation 12.2
|
Adverse Events
Midafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Somofilcon A
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