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To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B&L Multipurpose solution | Experimental | Bausch & Lomb Multipurpose Contact Lens Solution |
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| Alcon Multipurpose Solution | Active Comparator | Alcon OptiFree Replenish Multipurpose Contact Lens Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb Multipurpose Solution | Device | daily care of contact lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Assessment of Comfort and Cleanliness | Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score. | 2 weeks |
| Graded Slit Lamp Findings > Grade 2 |
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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 |
|---|---|---|---|---|---|---|
| Laser Focus Sdn Bhd, Vision Correction Centre | Jalan Kuning, Tamn Pelangi | Johor Bahru | 80400 | Malaysia |
Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials
361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | B&L Multipurpose Solution | Bausch & Lomb Multipurpose Contact Lens Solution |
| FG001 | Alcon Multipurpose Solution | Alcon OptiFree Replenish Multipurpose Contact Lens Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Alcon OptiFree Replenish Multipurpose Solution |
| Device |
daily care for contact lenses |
|
Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.
| 2 week follow-up visit |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | B&L Multipurpose Solution | Bausch & Lomb Multipurpose Contact Lens Solution |
| BG001 | Alcon Multipurpose Solution | Alcon OptiFree Replenish Multipurpose Contact Lens Solution |
| 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, Categorical | Count of Participants | 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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| 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 | Subjective Assessment of Comfort and Cleanliness | Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating. | All eyes | Posted | Mean | Standard Deviation | Scores on a scale | 7 days | eyes | Participants |
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| Secondary | Symptoms and Complaints | Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score. | All eligible, dispensed eyes | Posted | Mean | Standard Deviation | Score on a scale | 2 weeks | eyes | Participants |
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| Secondary | Graded Slit Lamp Findings > Grade 2 | Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2. | All dispensed, completed eyes | Posted | Number | eyes | 2 week follow-up visit | eyes | Participants |
|
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2 weeks
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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 | B&L Multipurpose Solution | Bausch & Lomb Multipurpose Contact Lens Solution | 0 | 175 | 0 | 175 | ||
| EG001 | Alcon Multipurpose Solution | Alcon OptiFree Replenish Multipurpose Contact Lens Solution | 0 | 175 | 0 | 175 |
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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.
Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen OD | Bausch & Lomb | (585) 338-6399 | robert.steffen@bausch.com |
| >=65 years |
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| Male |
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| Cleanliness at end of day |
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| Comfort at end of day |
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| eyes |
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| eyes |
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