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This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Day ACUVUE TruEye contact lens users | 1-Day ACUVUE TruEye contact lens users |
| |
| 1-Day ACUVUE MOIST contact lens users | 1-Day ACUVUE MOIST contact lens users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narafilcon B daily disposable soft contact lenses | Device | daily disposable soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel. | Self-report at 2 Week, 4 Month or 12 Month surveys |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbell | California | 95008 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27243356 | Derived | Hickson-Curran SB, Chalmers RL, Keay L, Gleason W. Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry. Eye Contact Lens. 2017 Sep;43(5):313-317. doi: 10.1097/ICL.0000000000000271. | |
| 25574042 | Derived | Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses |
| FG001 | 1-Day ACUVUE MOIST Contact Lens Users |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| etafilcon A daily disposable soft contact lenses | Device | daily disposable soft contact lenses |
|
|
| Baseline, 2 Week, 4 Month or 12 Month surveys |
| Fullerton |
| California |
| 92831-1615 |
| United States |
| Huntington Beach | California | 92647 | United States |
| Los Angeles | California | 90049 | United States |
| Mountain View | California | 94041 | United States |
| Newport Beach | California | 92660 | United States |
| Salinas | California | 93901 | United States |
| San Francisco | California | 94103 | United States |
| San Francisco | California | 94111 | United States |
| San Francisco | California | 94158 | United States |
| San Jose | California | 95131 | United States |
| Sunnyvale | California | 94086 | United States |
| Washington D.C. | District of Columbia | 20016 | United States |
| Boca Raton | Florida | 33431-7253 | United States |
| Boca Raton | Florida | 33432-3938 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Fort Lauderdale | Florida | 33328-2018 | United States |
| North Miami | Florida | 33181 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Wellington | Florida | 33414 | United States |
| Roswell | Georgia | 30075 | United States |
| Des Moines | Iowa | 50310 | United States |
| Shreveport | Louisiana | 71105 | United States |
| Belmont | Massachusetts | 02478 | United States |
| Cambridge | Massachusetts | 02138 | United States |
| Dedham | Massachusetts | 02026 | United States |
| Lake Hopatcong | New Jersey | 07849 | United States |
| New York | New York | 10022 | United States |
| New York | New York | 10036 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Gastonia | North Carolina | 28054 | United States |
| Cleveland | Ohio | 43081 | United States |
| Johnstown | Ohio | 43031 | United States |
| Westerville | Ohio | 43081 | United States |
| Brentwood | Tennessee | 37027-7552 | United States |
| Amarillo | Texas | 79119 | United States |
| Milwaukee | Wisconsin | 53227 | United States |
1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses
| 2 Week Survey Completed |
|
| 4 Month Survey Completed |
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| 12 Month Survey Completed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses |
| BG001 | 1-Day ACUVUE MOIST Contact Lens Users | 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses |
| BG002 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel. | The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria) | Posted | Number | participants | Self-report at 2 Week, 4 Month or 12 Month surveys |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous). | The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 Week, 4 Month or 12 Month surveys |
|
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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 | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses. | 0 | 601 | 0 | 601 | ||
| EG001 | 1-Day ACUVUE MOIST Contact Lens Users | 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses. | 0 | 570 | 0 | 570 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jurandir Araujo | Vistakon | +1 904 443-1379 | jaraujo7@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Not CL-Related Adverse Events with Office Visit |
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| "Yes" to Red Eye Question, but no Office Visit |
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