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The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon - PVP (multi-focal) | Experimental | The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon - PVP (multi-focal) | Device | The investigational contact lens must be worn at least six hours daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Eye Lid Margin Staining | Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2. | 30 days Post wear |
| Limbal Staining | Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported. | 30 Days Post Wear |
| Corneal Staining | The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported. | 30 Days Post Wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | SW1E6AU | United Kingdom |
A total of 23 subjects were enrolled in this study. Of the enrolled subjects, 3 did not meet the eligibility criteria and 20 were dispensed a study lens. All dispensed subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon PVP (Multi-focal) | All subjects wore the same study lenses throughout the duration of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon PVP (Multi-focal) | All subjects wore the same study lenses throughout the duration of this 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 | Upper Eye Lid Margin Staining | Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2. | The analysis population consists of all subjects that were dispensed a study lens. | Posted | Mean | Standard Deviation | mm^2 | 30 days Post wear |
|
|
Throughout the duration of the study. Approximately 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 | Etafilcon PVP (Multi-focal) | All subjects wore the same study lenses throughout the duration of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 3402 | TKarkkai@its.jnj.com |
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| Years |
|
| 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 | Limbal Staining | Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported. | The analysis population consist of all subjects that were dispensed a study lens. | Posted | Mean | Standard Deviation | percentage of limbal area | 30 Days Post Wear |
|
|
|
| Primary | Corneal Staining | The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported. | The analysis population consists of all subjects that were dispensed a study lens. | Posted | Mean | Standard Deviation | percentage of upper corneal quadrant | 30 Days Post Wear |
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| 0 |
| 20 |
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| 20 |
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