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The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A, then narafilcon B | Other | Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
|
| Narafilcon B, then delefilcon A | Other | Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses (DAILIES TOTAL1®) | Device | Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Quality of Vision | Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, MBA, PhD | Alcon Research | Study Director |
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Of the 330 participants enrolled, 17 were exited from the study prior to randomization and dispense of product.This reporting group includes all randomized and dispensed participants (313).
Participants were recruited from 18 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A, Then Narafilcon B | Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
| FG001 | Narafilcon B, Then Delefilcon A | Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First 8 Days of Wear |
| |||||||||||||
| Period 2 - Second 8 Days of Wear |
|
This reporting group includes all randomized and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Delefilcon A, Then Narafilcon B | Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
| BG001 | Narafilcon B, Then Delefilcon A |
| 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 | Overall Comfort | Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Day 8 |
|
Adverse events were collected for the duration of the study (3 months).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study medical device. This reporting group includes all randomized and dispensed participants.
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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 | Delefilcon A | Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, MBA, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) | Device | Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use |
|
| End of Day Comfort | End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Day 8 |
| NOT COMPLETED |
|
|
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2 |
|
|
| Secondary | Overall Quality of Vision | Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Day 8 |
|
|
|
| Secondary | End of Day Comfort | End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. | Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Day 8 |
|
|
|
| 0 |
| 313 |
| 0 |
| 313 |
| EG001 | Narafilcon B | Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2 | 0 | 313 | 0 | 313 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.