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A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RevitaLens OcuTec Multipurpose Solution (Investigational MPS) | Experimental |
| |
| Opti-Free RepleniSH Multipurpose Solution (MPS, Control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control) | Device | multi-purpose lens care solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With No Change in Corneal Staining | Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe. | Change from baseline after 1, 2, 4 and 6+ hours of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Medical Optics Inc. | Santa Ana | California | 92705 | United States |
Prior to baseline visit subjects were instructed to undergo a "washout period" where no contacts were worn for 12 hours. Slit lamp exam was conducted prior to randomized group assignment. Eyes were thoroughly rinsed with unit-dose aline before pre-soaked study lenses were inserted.
Recruitment of employees occurred 7/8/2010 - 10/1/2010 thru employee bulletin for study taking place at in-house optometric clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | RevitaLens and OptiFree | 30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RevitaLens and OptiFree | 30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control). |
| 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 | Number of Eyes With No Change in Corneal Staining | Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe. | per protocol | Posted | Number | eyes | Change from baseline after 1, 2, 4 and 6+ hours of wear |
|
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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 | RevitaLens and OptiFree | 30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Tarantino, Head, Clinical Research and Development | Abbott Medical Optics, Inc. | 714-247-8613 | nicholas.tarantino@amo.abbott.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Participants |
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| Sex/Gender, Customized | Study was performed in-house and strict confidentiality is required. Per Abbott In-House Study procedures, subject numbers and initials were used as identification. Limited access was given to data files to ensure confidentiality. Therefore, no gender data was collected for this study as it might reveal subjects identity to data entry personnel. | Number | participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 30 |
| 0 |
| 30 |
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