Trial Outcomes & Findings for Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population (NCT NCT03341923)
NCT ID: NCT03341923
Last Updated: 2019-04-16
Results Overview
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
Day 14, each product
Results posted on
2019-04-16
Participant Flow
Subjects were recruited from 4 study sites located in Japan.
Of the 151 enrolled, 17 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Participant milestones
| Measure |
DT1MF, Then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
|
AMMF, Then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
|
|---|---|---|
|
Period 1, First 14 Days of Wear
STARTED
|
67
|
67
|
|
Period 1, First 14 Days of Wear
COMPLETED
|
67
|
67
|
|
Period 1, First 14 Days of Wear
NOT COMPLETED
|
0
|
0
|
|
Period 2, Second 14 Days of Wear
STARTED
|
67
|
66
|
|
Period 2, Second 14 Days of Wear
COMPLETED
|
67
|
65
|
|
Period 2, Second 14 Days of Wear
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
DT1MF, Then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
|
AMMF, Then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
|
|---|---|---|
|
Period 2, Second 14 Days of Wear
Adverse Event
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Baseline characteristics by cohort
| Measure |
Overall
n=134 Participants
Delefilcon A multifocal contact lenses and etafilcon A multifocal contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14, each productPopulation: Full Analysis Set with data available
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Outcome measures
| Measure |
DT1MF
n=132 Participants
Delefilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.
|
AMMF
n=133 Participants
Etafilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.
|
|---|---|---|
|
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
|
97.0 percentage of subjects
|
91.0 percentage of subjects
|
Adverse Events
DT1MF Ocular
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
DT1MF Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AMMF Ocular
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
AMMF Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DT1MF Ocular
n=266 participants at risk
Eyes exposed to delefilcon A multifocal contact lenses
|
DT1MF Systemic
n=133 participants at risk
Subjects exposed to delefilcon A multifocal contact lenses
|
AMMF Ocular
n=268 participants at risk
Eyes exposed to etafilcon A multifocal contact lenses
|
AMMF Systemic
n=134 participants at risk
Subjects exposed to etafilcon A multifocal contact lenses
|
|---|---|---|---|---|
|
Eye disorders
Visual impairment
|
30.8%
82/266 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/133 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
26.1%
70/268 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/134 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
|
Eye disorders
Asthenopia
|
9.0%
24/266 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/133 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
5.2%
14/268 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/134 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
|
Eye disorders
Dry eye
|
2.3%
6/266 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/133 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
9.0%
24/268 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/134 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
|
Eye disorders
Ocular discomfort
|
2.3%
6/266 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/133 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
7.5%
20/268 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
0.00%
0/134 • Baseline through study completion, an average of 28 days
Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
|
Additional Information
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