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The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1, then TE | Other | Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. |
|
| TE, then DT1 | Other | Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear | Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis. | Day 10, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Clinical Development | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Japan, Ltd. for Trial Locations | Tokyo | 107-0052 | Japan |
Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).
Subjects were recruited from 6 study sites located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1, Then TE | Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. |
| FG001 | TE, Then DT1 | Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 10 Days of Wear |
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| Period 2, Second 10 Days of Wear |
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This analysis population includes all subjects who used the study device (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| 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 |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear | Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis. | This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set). | Posted | Number | percentage of subjects | Day 10, each product |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent.
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.
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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 | Pretreatment | All subjects who consented to participate in the study prior to initiation of study treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Manager | Alcon Japan Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Narafilcon A contact lenses | Device |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | Dailies Total1 | All subjects exposed to delefilcon A contact lenses | 0 | 96 | 7 | 96 |
| EG002 | TruEye | All subjects exposed to narafilcon A contact lenses | 0 | 98 | 23 | 98 |
| Punctate keratitis | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.