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The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP, then 1DAM | Other | Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. |
|
| 1DAM, then DACP | Other | Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lenses | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Investigator-Rated Lens Centration | Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean. | After 1 week of wear |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Investigator-Rated Lens Fit | Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean. | After 1 week of wear |
| Average Subjective Ratings Score (Lens Handling and Overall Vision) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa L. Zoota, MPH, CCRA | Alcon Research | Study Director |
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This reporting group includes all enrolled participants.
Participants were recruited from 5 study centers located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP, Then 1DAM | Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. |
| FG001 | 1DAM, Then DACP | Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Mean Investigator-Rated Lens Centration | Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean. | This analysis population includes all enrolled participants minus missing data. | Posted | Mean | Standard Deviation | units on a scale | After 1 week of wear |
|
Adverse events (AEs) were collected for the duration of the study (1 month). This analysis group includes (Safety Population). based on treatment-specific exposure
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, whether or not related to the medical device.
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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 | DACP | Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Alcon Japan, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Etafilcon A contact lenses | Device |
|
|
The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean. |
| After 1 week of wear |
| Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean. | After 1 week of wear |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Investigator-Rated Lens Fit | Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean. | This analysis population includes all enrolled participants minus missing data. | Posted | Mean | Standard Deviation | units on a scale | After 1 week of wear |
|
|
|
| Secondary | Average Subjective Ratings Score (Lens Handling and Overall Vision) | The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean. | This analysis population includes all enrolled participants minus missing data. | Posted | Mean | Standard Deviation | units on a scale | After 1 week of wear |
|
|
|
| Secondary | Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean. | This analysis population includes all enrolled participants minus missing data. | Posted | Mean | Standard Deviation | units on a scale | After 1 week of wear |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 1DAM | Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode. | 0 | 42 | 0 | 42 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Overall vision |
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| A lens becomes out of place |
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| Improves my vision/widens my vision |
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| My vision does not become blurry |
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| Do not lose a sense of perspective/distance |
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| Does not give me improper vision |
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| Enables me to see clearly at important occasion |
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| Improves my vision when playing sports |
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| Overall vision |
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