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To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multipurpose Solution - Rub Care | Experimental | Bausch & Lomb Multipurpose Solution for use with contact lens care |
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| Multipurpose Solution - No Rub Care | Experimental | Bausch & Lomb Multipurpose Solution for use with contact lens care |
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| Ciba Vision Aquify Multipurpose Solution | Active Comparator | Ciba Vision Aquify Multipurpose Solution for use with contact lens care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb Multipurpose Solution - Rub Care | Device | Daily care for contact lenses - rub care regimen |
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| Measure | Description | Time Frame |
|---|---|---|
| Slit-lamp Findings > Grade 2 | eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed. | Over 4 visits for 3 month period |
| Subjective Responses to Comfort Related Symptoms/Complaints | Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | Over 4 visits for the 3 month period |
| Contact Lens Deposits | Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy. | At each visit for 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohinder Merchea, OD, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Place Eye Care | Le Roy | New York | 14482 | United States |
Of the 541 participants enrolled 6 were ineligible at baseline. These subjects met the exclusion criteria. 535 participants participated in the study.
541 participants were enrolled in this 3 month study (1152 eyes). First participant was enrolled Mar 7, 2008 and last participant exited Aug 1, 2008. Participant were enrolled from 24 investigative sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multipurpose Solution - Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care |
| FG001 | Multipurpose Solution - No Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bausch & Lomb Multipurpose Solution - No Rub Care | Device | Daily care for contact lenses - no rub care regimen |
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| Ciba Vision Aquify Multipurpose Solution | Device | daily care for contact lenses |
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| FG002 | Ciba Vision Aquify Multipurpose Solution | Ciba Vision Aquify Multipurpose Solution for use with contact lens care |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multipurpose Solution - Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care |
| BG001 | Multipurpose Solution - No Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care |
| BG002 | Ciba Vision Aquify Multipurpose Solution | Ciba Vision Aquify Multipurpose Solution for use with contact lens care |
| BG003 | 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 |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | 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 > Grade 2 | eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed. | Over all follow-up visits, all dispensed eyes | Posted | Number | participants | Over 4 visits for 3 month period | eyes | Participants |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Subjective Responses to Comfort Related Symptoms/Complaints | Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits. | Posted | Mean | Standard Deviation | Scores on a Scale | Over 4 visits for the 3 month period | eyes | Participants |
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| ||||||||||||||||||||||||||||||||
| Primary | Contact Lens Deposits | Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy. | Lens deposits, All eligible, dispensed eyes. | Posted | Number | Eyes | At each visit for 3 months | eyes | Participants |
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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 | Multipurpose Solution - Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care | 0 | 178 | 0 | 178 | ||
| EG001 | Multipurpose Solution - No Rub Care | Bausch & Lomb Multipurpose Solution for use with contact lens care | 0 | 176 | 0 | 176 | ||
| EG002 | Ciba Vision Aquify Multipurpose Solution | Ciba Vision Aquify Multipurpose Solution for use with contact lens care | 0 | 181 | 0 | 181 |
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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 Sponsor, and such that confidential or proprietary information is not disclosed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen | Bausch & Lomb | (585) 338-6399 | robert.steffen@bausch.com |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| eyes |
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| eyes |
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