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This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental multi-purpose solution | Experimental | Multi-purpose contact lens care solution. |
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| ReNu MultiPlus Multi-Purpose Solution | Active Comparator | Multi-purpose contact lens care solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vistakon Investigational Multi-Purpose Solution I | Device | Multi-purpose contact lens care solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment. | 3 months |
| Distance Visual Acuity (LogMAR) | Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported. | Up to 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresno | California | United States | ||||
A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Multi-purpose Solution | Experimental multi-purpose contact lens care solution (Test treatment) |
| FG001 | ReNu MultiPlus Multi-Purpose Solution | Marketed multi-purpose contact lens care solution (Control Treatment). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ReNu MultiPlus Multi-Purpose Solution | Device | Multi-purpose contact lens care solution |
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| Pismo Beach |
| California |
| United States |
| Louisville | Colorado | United States |
| Bloomfield | Connecticut | United States |
| Jacksonville | Florida | United States |
| Overland Park | Kansas | United States |
| East Lansing | Michigan | United States |
| Warrensburg | Missouri | United States |
| Grove City | Ohio | United States |
| Grants Pass | Oregon | United States |
| Kingston | Pennsylvania | United States |
| Sioux Falls | South Dakota | United States |
| Memphis | Tennessee | United States |
| Salt Lake City | Utah | United States |
| Laramie | Wyoming | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Mutli-purpose Solution | Experimental multi-purpose solution (Test treatment) . |
| BG001 | ReNu Multi-purpose Solution | Marketed multi-purpose solution (Control Treatment). |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | 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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| 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 | Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment. | The analysis population consists of all subjects that were dispensed a solution during the course of the study. | Posted | Number | Subjects Eyes | 3 months | Subject Eye's | Subject Eye's |
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| Primary | Distance Visual Acuity (LogMAR) | Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | Up to 3 Months | Subject Eyes | Subject Eyes |
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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 | Experimental Multi-purpose Solution | Experimental multi-purpose contact lens care solution (Test treatment) | 1 | 200 | 0 | 200 | ||
| EG001 | ReNu MultiPlus Multi-Purpose Solution | Marketed multi-purpose contact lens care solution (Control Treatment). | 0 | 100 | 0 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microbial Keratitis | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D.- Research Principle Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-1290 | BPALL@its.jnj.com |
| Male |
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| Native Hawaiian or other Island Pacificer |
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| Asian |
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| White |
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| Other |
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| American Indian or Native Alaskian |
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| Tarsal Abnormalities |
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| Subject Eyes |
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