Trial Outcomes & Findings for Clinical Evaluation of Investigational Multifocal Toric Contact Lenses (NCT NCT03519282)
NCT ID: NCT03519282
Last Updated: 2020-05-04
Results Overview
Visual Acuity (measured in LogMAR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Up to 2 hours
Results posted on
2020-05-04
Participant Flow
Three subjects did not meet the inclusion criteria. Ten (10) subjects completed all visits and their data were included in the analysis.
Participant milestones
| Measure |
Test Multifocal Toric Lens Then Control Multifocal Toric
Subjects were randomized to wear the test multifocal toric lens then control multifocal toric lens during this crossover study.
comfilcon A multifocal toric lens: contact lens
|
Control Multifocal Toric Lens Then Test Multifocal Toric
Subjects were randomized to wear the control multifocal toric lens then test multifocal toric lens during this crossover study.
omafilcon A Multifocal Toric Lens: contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
|
First Intervention
COMPLETED
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
5
|
|
Second Intervention
COMPLETED
|
5
|
5
|
|
Second Intervention
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 and Omafilcon A Multifocal Toric Lenses
n=10 Participants
Subjects were randomized to wear the comfilcon A multifocal toric (test) or omafilcon A multifocal toric (control) lens, either as first or second lens during this cross over study.
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hoursVisual Acuity (measured in LogMAR)
Outcome measures
| Measure |
Test Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study.
comfilcon A multifocal toric lens: contact lens
|
Control Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study.
omafilcon A Multifocal Toric Lens: contact lens
|
|---|---|---|
|
Visual Acuity
Distance: Binocular
|
-0.08 logMAR
Standard Deviation 0.05
|
-0.06 logMAR
Standard Deviation 0.10
|
|
Visual Acuity
Distance: Monocular (dominate eye)
|
0.00 logMAR
Standard Deviation 0.09
|
-0.01 logMAR
Standard Deviation 0.06
|
|
Visual Acuity
Distant: Monocular (non-dominate eye)
|
0.02 logMAR
Standard Deviation 0.09
|
0.01 logMAR
Standard Deviation 0.10
|
|
Visual Acuity
Near: Binocular
|
0.10 logMAR
Standard Deviation 0.12
|
0.06 logMAR
Standard Deviation 0.12
|
|
Visual Acuity
Near: Monocular (dominate eye)
|
0.15 logMAR
Standard Deviation 0.17
|
0.16 logMAR
Standard Deviation 0.17
|
|
Visual Acuity
Near: Monocular (non-dominate eye)
|
0.17 logMAR
Standard Deviation 0.15
|
0.12 logMAR
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Up to 2 hoursSubjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Test Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study.
comfilcon A multifocal toric lens: contact lens
|
Control Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study.
omafilcon A Multifocal Toric Lens: contact lens
|
|---|---|---|
|
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
|
93 units on a scale
Standard Deviation 9
|
87 units on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Up to 2 hoursSubjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Test Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study.
comfilcon A multifocal toric lens: contact lens
|
Control Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study.
omafilcon A Multifocal Toric Lens: contact lens
|
|---|---|---|
|
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
|
95 units on a scale
Standard Deviation 9
|
95 units on a scale
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Up to 2 hoursSubjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Outcome measures
| Measure |
Test Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study.
comfilcon A multifocal toric lens: contact lens
|
Control Multifocal Toric Lens
n=10 Participants
Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study.
omafilcon A Multifocal Toric Lens: contact lens
|
|---|---|---|
|
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
|
94 units on a scale
Standard Deviation 8
|
90 units on a scale
Standard Deviation 20
|
Adverse Events
Test Multifocal Toric Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omafilcon A Multifocal Toric Lens
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