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The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Experimental | Multi-Purpose Solution to be used for disinfecting contact lenses. |
|
| Ciba's Multi-Purpose Solution | Active Comparator | Multi-Purpose Solution to be used for disinfecting contact lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Device | Lens care product for disinfecting lenses on a daily basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort-related Symptoms/Complaints | Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries. | At dispensing visit and each follow-up visit at week 2 and week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.
This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bausch & Lomb Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting contact lenses. |
| FG001 | Ciba's Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting contact lenses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled Participants |
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| ||||||||||||||||||
| Eligible Participants |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bausch & Lomb Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting contact lenses. |
| BG001 | Ciba's Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting 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, Customized | Number |
| 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-related Symptoms/Complaints | Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries. | Summaries included all eligible, dispensed participants, with participants summarized under the study products received. | Posted | Mean | Standard Deviation | Units on a scale | At dispensing visit and each follow-up visit at week 2 and week 4. | eyes | Participants |
|
1 month
Adverse events measured by eye
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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 | Bausch & Lomb Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting contact lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Reindel, OD, MS | Bausch & Lomb Incorporated | (585) 338-8129 | william.reindel@bausch.com |
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| Ciba's Multi-Purpose Solution | Device | Lens care product for disinfecting lenses on a daily basis. |
|
| Over all visits for 1 month |
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| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Multi-Purpose Solution to be used for disinfecting contact lenses. |
|
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| Secondary | Slit Lamp Findings | Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits. | Greater than grade 2 for all dispensed eyes with non-missing scores | Posted | Number | eyes | Over all visits for 1 month | eyes | Participants |
|
|
|
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | Ciba's Multi-Purpose Solution | Multi-Purpose Solution to be used for disinfecting contact lenses. | 0 | 156 | 0 | 156 |
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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 Sponsor.