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This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | Contact lenses to be worn in a daily wear modality |
|
| senofilcon A for Astigmatism | Experimental | Contact lenses to be worn in a daily wear modality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device |
| ||
| senofilcon A for Astigmatism |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Successfully Re-fitted Subjects | Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | 32205 | United States | |||
A total of 199 subjects were enrolled in the study; 7 subjects were enrolled but not randomized. 18 subjects were discontinued and 174 subjects completed the study. Of those 174 completed subjects, 5 subjects had major protocol deviations; 169 subjects were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Senfilcon A) | Subjects that were randomized to receive the Control lens for the duration of the study. |
| FG001 | Test (Senofilcon A) | Subjects that were randomized to receive theTest lens for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| Saint Augustine |
| Florida |
| 32092 |
| United States |
| Sarasota | Florida | 34232 | United States |
| Roswell | Georgia | 30076 | United States |
| Bloomington | Illinois | 61701 | United States |
| Raytown | Missouri | 60415 | United States |
| Vestal | New York | 13850 | United States |
| Raleigh | North Carolina | 27615 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Memphis | Tennessee | 38119 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The analysis population consists of all subjects that were enrolled into the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Senfilcon A) | Consists of subjects that were dispensed at least one Control lens. |
| BG001 | Test (Senofilcon A) | Consists of subjects that were dispensed at least one Test lens. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | Proportion of Successfully Re-fitted Subjects | Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology. | The analysis population includes all subjects who have completed all study visits without a major protocol deviation. | Posted | Number | percentage of Subjects | 4 weeks |
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Throughout the duration of the study- approximately 5 months
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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 | Control (Senofilcon A) | Subjects that were randomized to receive the Control lens for the duration of the study. | 0 | 102 | 0 | 102 | ||
| EG001 | Test (Senofilcon A) | Subjects that were randomized to receive the Test lens for the duration of the study. | 0 | 90 | 0 | 90 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jurandir Araujo, Clinical Compliance Manager | Johnson & Johnson Vision Care, Inc. | 9044431379 | jaraujo7@its.jnj.com |
| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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