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The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1MF, then AMMF | Other | 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 | Other | Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A multifocal contact lenses | Device | Silicone hydrogel multifocal contact lenses for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Investigator-graded Lens Centration of "Optimal" | 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. | Day 14, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Koto-Ku | Tokyo | 136-0071 | Japan | ||
| Alcon Investigative Site |
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Of the 151 enrolled, 17 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Subjects were recruited from 4 study sites located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | AMMF, Then DT1MF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, First 14 Days of Wear |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2018 | Mar 15, 2019 |
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|
| Etafilcon A multifocal contact lenses | Device | Hydrogel multifocal contact lenses for daily disposable wear |
|
|
| Nakano-ku |
| Tokyo |
| 164-0001 |
| Japan |
| Alcon Investigative Site | Shinagawa-Ku | Tokyo | 141-0021 | Japan |
| Alcon Investigative Site | Taitō City | Tokyo | 110-0005 | Japan |
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
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| NOT COMPLETED |
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| Period 2, Second 14 Days of Wear |
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This analysis population includes all subjects who used the investigational medical devices and provided data after the use. The lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A multifocal contact lenses and etafilcon A multifocal contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Subjects With Investigator-graded Lens Centration of "Optimal" | 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. | Full Analysis Set with data available | Posted | Number | percentage of subjects | Day 14, each product |
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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."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DT1MF Ocular | Eyes exposed to delefilcon A multifocal contact lenses | 0 | 266 | 0 | 266 | 88 | 266 |
| EG001 | DT1MF Systemic | Subjects exposed to delefilcon A multifocal contact lenses | 0 | 133 | 0 | 133 | 0 | 133 |
| EG002 | AMMF Ocular | Eyes exposed to etafilcon A multifocal contact lenses | 0 | 268 | 0 | 268 | 82 | 268 |
| EG003 | AMMF Systemic | Subjects exposed to etafilcon A multifocal contact lenses | 0 | 134 | 0 | 134 | 0 | 134 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA (21.0) | Systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA (21.0) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (21.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Manager, Vision Care | Alcon Japan, Ltd. | +81.3.6899.5061 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2015 | Mar 15, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| McNemar |
| 0.0455 |
| Difference in proportion |
| 6.1 |
| 2-Sided |
| 95 |
| 0.2 |
| 11.9 |
| Superiority |
After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated. |