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To evaluate and compare the performance of a new contact lens to a marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAPVPDE/EADE | Other | etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. |
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| EADE/EAPVPDE | Other | etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A with print and PVP for dark eyes (EAPVPDE) | Device | A daily disposable contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120. | After 7 to 9 days of lens wear |
| Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | After 7 to 9 days of lens wear |
| Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | After 7 to 9 days of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloomfield | Connecticut | 06002 | United States | |||
Of those 103 enrolled subjects, 3 subjects did not receive the study article.
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| ID | Title | Description |
|---|---|---|
| FG000 | EAPVPDE/EADE | etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods. |
| FG001 | EADE/EAPVPDE |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| etafilcon A control lens (EADE) | Device | A marketed daily disposable contact lens |
|
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Overland Park | Kansas | 66207 | United States |
| Jamestown | New York | 14750 | United States |
| Kingston | Pennsylvania | 18704 | United States |
| Moon Township | Pennsylvania | 15108 | United States |
etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods. |
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| NOT COMPLETED |
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| Period 2 |
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Baseline summary was conducted on all enrolled subjects who received study lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All enrolled subjects who received study lenses. |
| 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 | ||||||||||||
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120. | Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | After 7 to 9 days of lens wear |
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| Primary | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | After 7 to 9 days of lens wear |
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| Primary | Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | After 7 to 9 days of lens wear |
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Adverse events were recorded when the subjects were exposed to the Investigational lenses.
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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 | EAPVPDE | etafilcon A material incorporating PVP in the blister packaging solution. | 0 | 100 | 0 | 100 | ||
| EG001 | EADE | etafilcon a existing, daily disposable contact lens. | 0 | 100 | 0 | 100 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mayers, OD, FAAO | Johnson & Johnson Vision Care | 904-443-3252 | mmayers@its.jnj.com |
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