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The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal Test Contact Lens | Experimental | Subjects will wear the test lenses at least six hours per day, at least five days per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifocal Test Contact lens | Device | Used in a daily wear modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Successful Contact Lens Wearers | Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers. | 2 months post wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Eye Center | Pensacola | Florida | 32503 | United States | ||
| Ocular Technology Group-International |
A total of 113 enrolled into this study. Of the enrolled, 5 subjects did not meet the eligibility criteria and 108 subjects were dispensed the study lens. Of the dispensed subjects 79 completed the study while 29 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon -PVP (Multi-focal) | All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects that were dispensed the study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects in that were dispensed the study lens. |
| 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 Successful Contact Lens Wearers | Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Proportion of Subjects | 2 months post wear |
|
Throughout the duration of the study. Approximately 2-months 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 | Etafilcon -PVP (Multi-focal) | All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904 443-3402 | TKarkkai@its.jnj.com |
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| London |
| SW1E 6AU |
| United Kingdom |
| Lost to Follow-up |
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| Protocol Violation |
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| No longer meet eligibility criteria |
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| Unsatisfactory Visual Response |
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| 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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| 0 |
| 108 |
| 0 |
| 108 |
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