Trial Outcomes & Findings for DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance (NCT NCT02403180)
NCT ID: NCT02403180
Last Updated: 2016-08-18
Results Overview
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
COMPLETED
NA
70 participants
Day 5, each product
2016-08-18
Participant Flow
Participants were recruited from one investigational center located in Spain.
This reporting group includes all enrolled participants (70).
Participant milestones
| Measure |
DACP MF, Then PROCLEAR 1D MF
Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
|
PROCLEAR 1D MF, Then DACP MF
Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
36
|
34
|
|
Pre-Treatment Period
COMPLETED
|
36
|
33
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
1
|
|
Period 1 (5 Days)
STARTED
|
36
|
33
|
|
Period 1 (5 Days)
Randomized
|
36
|
33
|
|
Period 1 (5 Days)
COMPLETED
|
36
|
33
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (5 Days)
STARTED
|
36
|
33
|
|
Period 2 (5 Days)
COMPLETED
|
36
|
32
|
|
Period 2 (5 Days)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
DACP MF, Then PROCLEAR 1D MF
Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
|
PROCLEAR 1D MF, Then DACP MF
Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
|
|---|---|---|
|
Pre-Treatment Period
Withdrawal by subject prior to treatment
|
0
|
1
|
|
Period 2 (5 Days)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Baseline characteristics by cohort
| Measure |
DACP MF, Then PROCLEAR 1D MF
n=36 Participants
Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
|
PROCLEAR 1D MF, Then DACP MF
n=34 Participants
Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 4.67 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 3.88 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 4.32 • n=5 Participants
|
|
Age, Customized
41-50 years
|
15 participants
n=5 Participants
|
20 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Age, Customized
51-60 years
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Age, Customized
61-65 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5, each productPopulation: Intention to treat participants with non-missing observations
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
Outcome measures
| Measure |
Proclear 1 Day MF
n=69 Participants
Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
|
DACP MF
n=68 Participants
Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
|
|---|---|---|
|
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
|
40.6 arcsec
Standard Deviation 11.67
|
30.7 arcsec
Standard Deviation 8.67
|
SECONDARY outcome
Timeframe: Day 5, each productPopulation: Intention to treat participants with non-missing observations
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.
Outcome measures
| Measure |
Proclear 1 Day MF
n=69 Participants
Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
|
DACP MF
n=68 Participants
Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
|
|---|---|---|
|
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
for the Near Region
|
0.04 diopter*logMar
Standard Deviation 0.051
|
0.07 diopter*logMar
Standard Deviation 0.061
|
|
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
for the Intermediate Region
|
0.17 diopter*logMar
Standard Deviation 0.092
|
0.21 diopter*logMar
Standard Deviation 0.077
|
Adverse Events
Proclear 1 Day MF
DACP MF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Affairs Franchise Head, Vision Care
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER