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The purpose of this clinical trial is to compare the overall lens fit acceptance of two different soft contact lenses in an Asian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A with additive printed limbal ring | Experimental | Each subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. |
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| etafilcon A | Active Comparator | Each subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Each study subject will be exposed to both test lenses following a washout period of five minutes between test periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Lens Fit Acceptance | The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp. | 15 mins post insertion |
| Cosmetic Lens Fit Acceptance | The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp. | 15 mins post insertion |
| Lens Does Not Exhibit "Hula Hoop" Effect | The number of subjects that did not exhibit a "hula hoop" effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp. | 15 mins post insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley | California | 94720 | United States | |||
206 subjects were enrolled in this study. 16 subjects did not meet the eligibility criteria. 190 subjects were dispensed lenses and, 177 subjects completed all study visits without a major protocol deviation. 13 subjects were recorded as having protocol violations. No subjects were discontinued during this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 1/Test 2 | Subjects who received test lens 1 first and then received test lens 2. |
| FG001 | Test 2/Test 1 | Subjects who received test lens 2 first and then received test lens 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Fullerton |
| California |
| 92831 |
| United States |
| New York | New York | 12207 | United States |
| Cleveland | Ohio | 44106 | United States |
| Dallas | Texas | 75390 | United States |
| Houston | Texas | 77204 | United States |
| Waterloo | Ontario | N2L 3G1 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All subjects that were dispensed a test article during the study. |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Mechanical Lens Fit Acceptance | The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Number | Eyes | 15 mins post insertion | Eyes | Eyes |
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| Primary | Cosmetic Lens Fit Acceptance | The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Number | Eyes | 15 mins post insertion | Eyes | Eyes |
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| Primary | Lens Does Not Exhibit "Hula Hoop" Effect | The number of subjects that did not exhibit a "hula hoop" effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp. | The analysis population consists of subjects that completed all study visits, without a major protocol deviation | Posted | Number | Subject | 15 mins post insertion |
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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 | Test 1 | Subjects that received Test lens 1 during the first or second period of the study. | 0 | 95 | 0 | 95 | ||
| EG001 | Test 2 | Subjects that received Test lens 2 during the first or second period of the study. | 0 | 95 | 0 | 95 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Jansen,O.D.,M.S., FAAO | Johnson and Johnson Vision Care Inc. | 904-443-3500 | 1396 | mjanse12@ITS.JNJ.com |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Eyes |
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