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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Opti-Free® RepleniSH® MPDS |
|
| 2 | Active Comparator | Renu MultiPlus® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opti-Free® RepleniSH® MPDS | Device | soft contact lens disinfecting solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective, In-vivo Soft Contact Lens Wettability Index | The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Questionnaire Response | Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Zikos, OS, MS | MVA/IVR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MVA/IVR | New York | New York | 10022 | United States |
32 subjects were recruited and enrolled in the study. No subjects had to be excluded.
Recruitment of patients was conducted by approaching the patients seen in the practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 - ReNu MultiPlus First, Opti-Free RepleniSH Second | Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period |
| FG001 | 2 - Opti-Free RepleniSH First, ReNu MultiPlus Second | Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 - ReNu MultiPlus First | Used ReNu MultiPlus first, Opti-Free RepleniSH Second |
| BG001 | 2 - Opti-Free RepleniSH First | Opti-Free RepleniSH first, ReNu MultiPlus Second |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Objective, In-vivo Soft Contact Lens Wettability Index | The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens. | Per protocol. All participants that completed both arms were analysed. | Posted | Mean | Standard Deviation | wettability index | 2 weeks |
|
Length of study was 24 to 32 days.
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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 | 1 - ReNu MultiPlus First | Used ReNu MultiPlus first, Opti-Free RepleniSH Second |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Zikos | Manhattan Vision Associates / Institute for Vision Research | 2126884277 | gzikos@mvaivr.com |
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| ReNu MultiPlus® |
| Device |
soft contact lens disinfecting solution |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Subject Questionnaire Response | Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 2 - Opti-Free RepleniSH First | Opti-Free RepleniSH first, ReNu MultiPlus Second | 0 | 16 | 0 | 16 |
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