Trial Outcomes & Findings for Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism (NCT NCT04404725)
NCT ID: NCT04404725
Last Updated: 2022-03-03
Results Overview
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Day 28
Results posted on
2022-03-03
Participant Flow
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
Participant milestones
| Measure |
Comfilcon A Then Samfilcon A
Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.
|
Samfilcon A Then Comfilcon A
Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.
|
|---|---|---|
|
First Intervention
STARTED
|
32
|
31
|
|
First Intervention
COMPLETED
|
32
|
29
|
|
First Intervention
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
32
|
29
|
|
Second Intervention
COMPLETED
|
31
|
27
|
|
Second Intervention
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Comfilcon A Then Samfilcon A
Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.
|
Samfilcon A Then Comfilcon A
Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
|
Second Intervention
Adverse Event
|
1
|
1
|
|
Second Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=64 Participants
Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants.
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=64 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 8.9 • n=64 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=64 Participants
|
|
Region of Enrollment
Canada
|
48 participants
n=64 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
Outcome measures
| Measure |
Comfilcon A
n=55 Participants
Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.
|
Samfilcon A
n=56 Participants
Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
|
|---|---|---|
|
Ease of Lens Handling at Insertion
|
8.6 score on a scale
Standard Deviation 1.6
|
8.8 score on a scale
Standard Deviation 1.8
|
Adverse Events
Comfilcon A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Samfilcon A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Comfilcon A
n=61 participants at risk
Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.
|
Samfilcon A
n=63 participants at risk
Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
|
|---|---|---|
|
Eye disorders
conjunctivitis
|
8.2%
5/61 • Number of events 5 • One month on each study lenses, a total of two months.
|
7.9%
5/63 • Number of events 5 • One month on each study lenses, a total of two months.
|
|
Eye disorders
Infiltrative Keratitis
|
3.3%
2/61 • Number of events 2 • One month on each study lenses, a total of two months.
|
0.00%
0/63 • One month on each study lenses, a total of two months.
|
|
General disorders
Non-Ocular Event
|
3.3%
2/61 • Number of events 2 • One month on each study lenses, a total of two months.
|
6.3%
4/63 • Number of events 4 • One month on each study lenses, a total of two months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place