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This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon C | Experimental | Vistakon Investigational Contact Lens (Test) |
|
| comfilcon A | Active Comparator | Marketed Monthly Wear Contact Lens (Control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon C | Device |
| ||
| comfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes Grade 3 or Higher SLF | Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens. | Up to 6 Month Follow-up |
| Visual Acuity (logMAR) | The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens. | Up to 6 Month Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Omega Vision Center, PA / Sabal Eye Care |
A total of 105 subjects were enrolled into this study. Of the enrolled subjects all were dispensed a study lens. Out of all the dispensed subjects 103 completed the study while 2 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon C | Subjects that wore the senofilcon C lens throughout the entire duration of the study. |
| FG001 | Comfilcon A | Subjects that wore the comfilcon A lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects that were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon C | Subjects that wore the senofilcon C lens throughout the entire duration of the study. |
| BG001 | Comfilcon A | Subjects that wore the comfilcon A lens throughout the entire duration of the study. |
| 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 | Proportion of Eyes Grade 3 or Higher SLF | Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens. | Subjects that were dispensed a study lens. | Posted | Number | Proporiton of Subject Eyes | Up to 6 Month Follow-up | Subject Eyes | Subject Eyes |
|
Throught the duration of the study. Approximately 3 months per subject.
NCT02625233 is a continuation of NCT02515994. Each study was approximately 3 months duration for each subject(i.e. if a subject was enrolled into both studies they wore the lens a total of 6 months). Refer to the adverse event information for study NCT02515994 for the previous 3 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 | Senofilcon C | Subjects that wore the senofilcon C lens throughout the entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan, O.D., FAAO Principal Research Optometrist | Johson & Johnson Vision Care Inc. | 904 443-1474 | KCANAVA2@its.jnj.com |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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|
| Longwood |
| Florida |
| 32779 |
| United States |
| Eyecare Associates | Bloomington | Illinois | 61701 | United States |
| Dr. Debbie H. Kim, OD | Closter | New Jersey | 07624 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Dr. William Bogus | Salt Lake City | Utah | 84106 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Comfilcon A |
Subjects that wore the comfilcon A lens throughout the entire duration of the study. |
|
|
| Primary | Visual Acuity (logMAR) | The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens. | Subjects that completed all study visits. | Posted | Mean | Standard Deviation | LogMAR | Up to 6 Month Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Comfilcon A | Subjects that wore the comfilcon A lens throughout the entire duration of the study. | 0 | 56 | 0 | 56 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 4 Month Follow-up N=94, N=112 |
|
| 5 Month Follow-up N=94, N=112 |
|
| 6 Month Follow-up N=94, N=112 |
|