Trial Outcomes & Findings for Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses (NCT NCT03417557)
NCT ID: NCT03417557
Last Updated: 2020-05-04
Results Overview
Visual acuity is assessed for test and control lens on a logMAR chart
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
up to 3 hours
Results posted on
2020-05-04
Participant Flow
Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.
Participant milestones
| Measure |
Comfilcon A Lens Then Omafilcon B Lens
Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study.
Comfilcon A lens (test): contact lens
|
Omafilcon B Lens Then Comfilcon A
Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study.
Omafilcon B lens (control): contact lens
|
|---|---|---|
|
1st Intervention (3 Hours)
STARTED
|
8
|
9
|
|
1st Intervention (3 Hours)
COMPLETED
|
8
|
9
|
|
1st Intervention (3 Hours)
NOT COMPLETED
|
0
|
0
|
|
2nd Intervention (3 Hours)
STARTED
|
9
|
8
|
|
2nd Intervention (3 Hours)
COMPLETED
|
9
|
8
|
|
2nd Intervention (3 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Comfilcon A Lens (Test) and Omafilcon B (Control)
n=17 Participants
Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study.
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 7 • n=17 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: up to 3 hoursVisual acuity is assessed for test and control lens on a logMAR chart
Outcome measures
| Measure |
Comfilcon A Lens (Test)
n=17 Participants
Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.
Comfilcon A lens (test): contact lens
|
Omafilcon B Lens (Control)
n=17 Participants
Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.
Omafilcon B lens (control): contact lens
|
|---|---|---|
|
Visual Acuity
Distance: Binocular
|
-0.01 logMAR
Standard Deviation 0.09
|
-0.03 logMAR
Standard Deviation 0.16
|
|
Visual Acuity
Distance: Monocular (dominate eye)
|
-0.05 logMAR
Standard Deviation 0.12
|
0.06 logMAR
Standard Deviation 0.21
|
|
Visual Acuity
Distant: Monocular (non-dominate eye)
|
0.02 logMAR
Standard Deviation 0.13
|
0.13 logMAR
Standard Deviation 0.22
|
|
Visual Acuity
Near: Binocular
|
0.05 logMAR
Standard Deviation 0.09
|
0.03 logMAR
Standard Deviation 0.07
|
|
Visual Acuity
Near: Monocular (dominate eye)
|
0.14 logMAR
Standard Deviation 0.11
|
0.17 logMAR
Standard Deviation 0.13
|
|
Visual Acuity
Near: Monocular (non-dominate eye)
|
0.10 logMAR
Standard Deviation 0.13
|
0.04 logMAR
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: up to 3 hoursSubjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Comfilcon A Lens (Test)
n=17 Participants
Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.
Comfilcon A lens (test): contact lens
|
Omafilcon B Lens (Control)
n=17 Participants
Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.
Omafilcon B lens (control): contact lens
|
|---|---|---|
|
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
|
91 units on a scale
Standard Deviation 8
|
79 units on a scale
Standard Deviation 24
|
SECONDARY outcome
Timeframe: up to 3 hoursSubjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Comfilcon A Lens (Test)
n=17 Participants
Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.
Comfilcon A lens (test): contact lens
|
Omafilcon B Lens (Control)
n=17 Participants
Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.
Omafilcon B lens (control): contact lens
|
|---|---|---|
|
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
|
87 units on a scale
Standard Deviation 12
|
82 units on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: up to 3 hoursSubjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Comfilcon A Lens (Test)
n=17 Participants
Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.
Comfilcon A lens (test): contact lens
|
Omafilcon B Lens (Control)
n=17 Participants
Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.
Omafilcon B lens (control): contact lens
|
|---|---|---|
|
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
|
84 units on a scale
Standard Deviation 17
|
79 units on a scale
Standard Deviation 26
|
Adverse Events
Comfilcon A Lens (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omafilcon B Lens (Control)
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