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This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multipurpose Solution #1 | Experimental | B&L Renu Fresh Multipurpose Solution |
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| Multipurpose Solution #2 | Experimental | OptiFree Replenish Multipurpose Solution |
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| Multipurpose Solution #3 | Experimental | Ciba ClearCare Multipurpose Solution |
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| Multipurpose Solution #4 | Active Comparator | Saline Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multipurpose Solution #1 | Other | B&L Renu Fresh Multipurpose Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Severity | Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit. | Baseline, 2 Hour Period, 4 Hour Period |
| Corneal Staining Area | Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit. | Baseline, 2 Hour Period, 4 Hour Period |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort | Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort) | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours |
| Subjective Dryness | Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Andrasko, OD, MS | Erdey/Searcy Eye Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erdey/Searcy Eye Group | Columbus | Ohio | 43213 | United States |
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| Label | URL |
|---|---|
| Click here for more information about similar studies | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multipurpose Solution | To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multipurpose Solution | To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses |
| 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 |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Subjective Comfort | Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort) | Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort) | Posted | Mean | Standard Deviation | units on a scale | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours |
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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 | Multipurpose Solution | To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Andrasko, MS | Erdy/Searcy Group | (614) 459-3363 | gandrask@columbus.rr.com |
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| Multipurpose Solution #2 | Other | Optifree Replenish Multipurpose Solution |
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| Mutlipurpose Solution #3 | Other | Ciba ClearCare Multipurpose Solution |
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| Multipurpose Solution #4 | Other | Saline Solution |
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| Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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Ciba ClearCare Multipurpose Solution |
| OG003 | Multipurpose Solution #4 | Saline Multipurpose Solution |
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| Secondary | Subjective Dryness | Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist) | Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist) | Posted | Mean | Standard Deviation | units on a scale | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours |
|
|
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| Primary | Corneal Staining Severity | Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit. | Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit. | Posted | Mean | Full Range | units on a scale | Baseline, 2 Hour Period, 4 Hour Period |
|
|
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| Primary | Corneal Staining Area | Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit. | Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 Hour Period, 4 Hour Period |
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| 0 |
| 32 |
| 0 |
| 32 |
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| 2 Hour Period |
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| 4 Hour Period |
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| 2 Hour Period |
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| 3 Hour Period |
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| 2 Hour Period |
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| 3 Hour Period |
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