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The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReNu in Currently Marketed Bottle | Active Comparator | Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. |
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| ReNu in Clear Resin Bottle | Experimental | Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. | Device | Daily care for contact lenses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating. | Over-all follow-up visits from baseline to 1 month |
| Slit Lamp Findings | Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe. | Over-all follow-up visits from baseline to1 month |
| Lens Deposits | Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy. | Over-all study visits, baseline to 1-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, PhD, MCOptom | Bausch & Lomb Incorporated | Study Director |
| James Ferrari, OD | James Ferrari, OD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Ferrari, OD | Rochester | New York | 14609 | United States |
312 Participants were enrolled, 2 participants were ineligible at baseline but were dispensed lens care solution and completed the study. 2 participants were not dispensed lens care solution. 308 eligible subjects started the study, 8 were discontinued during the study. 300 participants completed the study.
This study was conducted in 23 investigative sites in the United States. First participant was enrolled 3/19/2008, last participant exited the study 5/19/08.
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| ID | Title | Description |
|---|---|---|
| FG000 | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care. |
| FG001 | Clear Bottle ReNu MultiPlus Multi-Purpose Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. | Device | Daily care for contact lenses |
|
Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care. |
| BG001 | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care. |
| 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, Customized | Number | Participants |
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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 | Comfort | Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating. | Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores) | Posted | Mean | Standard Deviation | Units on a Scale | Over-all follow-up visits from baseline to 1 month | eyes | Participants |
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| Primary | Slit Lamp Findings | Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe. | Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible). | Posted | Number | Eyes | Over-all follow-up visits from baseline to1 month | eyes | Participants |
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| Primary | Lens Deposits | Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy. | Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data) | Posted | Number | Eyes | Over-all study visits, baseline to 1-month | eyes | Participants |
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One month
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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 | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care. | 0 | 157 | 0 | 157 | ||
| EG001 | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care. | 0 | 151 | 0 | 151 |
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The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with the Sponser, and such that confidential or proprietary information is not disclosed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Cairns | Bausch & Lomb Incorporated | (585) 338-5170 | gerard.cairns@bausch.com |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Burning/Stinging on Insertion |
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| Irritation |
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| Itching |
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| Dryness |
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| Redness |
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| Vision |
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| Lens Cleanliness |
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| Lens Handling |
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| eyes |
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| eyes |
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