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The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B&L Investigational Contact Lens | Experimental | The Bausch + Lomb investigational silicone hydrogel contact lens |
|
| B&L PureVision Contact Lens | Active Comparator | The Bausch + Lomb PureVision silicone hydrogel contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B&L Investigational Contact Lens | Device | Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months. | 4 visits over 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp > Grade 2 | Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
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166 participants were enrolled in the study with 158 participants completing the study. A minimum of 68 participants were to be of Japanese descent (both maternal and paternal grandparents born in Japan) for submission to the Japanese Regulatory Agency.
This was a three month study enrolling 166 participants from 12 investigative sites in the United States. First participant was enroled on 08/08/2011, and last participant exited the study on 12/08/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | B&L Investigational Contact Lens | The Bausch + Lomb investigational silicone hydrogel contact lens B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
| FG001 | B&L PureVision Contact Lens | The Bausch + Lomb PureVision silicone hydrogel contact lens B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Eligible, Dispensed Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | B&L Investigational Contact Lens | The Bausch + Lomb investigational silicone hydrogel contact lens B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
| BG001 | B&L PureVision Contact Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months. | All Eligible, Dispensed Eyes | Posted | Least Squares Mean | Standard Deviation | LogMAR | 4 visits over 3 months | Eyes | Participants |
|
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 | B&L Investigational Contact Lens | The Bausch + Lomb investigational silicone hydrogel contact lens B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | 585-338-6399 | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| B&L PureVision Contact Lens | Device | Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
|
| Symptoms/complaints |
|
| Lack of Motivation |
|
| Cannot maintain visits |
|
The Bausch + Lomb PureVision silicone hydrogel contact lens B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Slit Lamp > Grade 2 | Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses. | Number of dispensed eyes with non-missing scores in each treatment group. | Posted | Number | eyes (2 per participant) | 3 months | Eyes | Participants |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | B&L PureVision Contact Lens | The Bausch + Lomb PureVision silicone hydrogel contact lens B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly. | 0 | 83 | 0 | 83 |
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