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This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test / Control Sequence | Experimental | Subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality. |
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| Control / Test Sequence | Active Comparator | Subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Contact Lens | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Wearing Time | Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens. | 2-week follow-up |
| Visual Acuity (LogMAR) | Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported. | 2-week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Eye Elements Eyecare |
A total of 142 subjects were enrolled into this study. Of the enrolled 1 subject did not meet the eligibility criteria and 141 were dispensed a study lens. Of the dispensed subjects 125 completed the study and 16 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A(Test)/Senofilcon A(Control) | Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second. |
| FG001 | Senofilcon A(Control)/Senofilcon A(Test) | Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects that were dispensed at least 1 study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one study lens. |
| 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 |
| 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 | Contact Lens Wearing Time | Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours | 2-week follow-up |
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Throughout the duration of the study. Approximately 6 weeks per subject.
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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 A (Test) | Subjects that wore the test lens senofilcon A during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, OD, MS, FAAO -Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904 443-1290 | BPALL@its.jnj.com |
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| Control Contact Lens | Device |
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| Jacksonville |
| Florida |
| United States |
| Golden Vision | Sarasota | Florida | United States |
| Advantage Eyecare Associates, LLC | Neodesha | Kansas | United States |
| Advanced Eyecare, PC | Raytown | Missouri | United States |
| Professional Vision Care | Westerville | Ohio | United States |
| Timothy R. Poling, OD | Roanoke | Virginia | United States |
| Protocol Violation |
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| Withdrawal by Subject |
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| Adverse Event |
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| NOT COMPLETED |
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| 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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| Primary | Visual Acuity (LogMAR) | Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 2-week Follow-up | Eyes | Eyes |
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| 0 |
| 141 |
| 0 |
| 141 |
| EG001 | Senofilcon A (Control) | Subjects that wore the control lens senofilcon A lens during the first or second period of the study. | 0 | 141 | 0 | 141 |
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