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The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bausch & Lomb new daily disposable | Experimental | New daily disposable contact lenses |
|
| Johnson & Johnson Acuvue Moist | Active Comparator | Contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb new daily disposable | Device | Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up. | Dispensing Visit and 1 week follow-up |
| Slit Lamp Examination > Grade 2 | Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2. | All study visits from screening through 2 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bev Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
102 participants(204 eyes) were enrolled in this study.
This was a two week, multicenter, open label, bilateral, crossover study. First Participant was enrolled 08/23/2010 and last participant exited the study 10/08/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | B & L Daily Disposable Lens, Then J & J Acuvue Moist | Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
| FG001 | J & J Acuvue Moist, Then B & L Daily Disposable Lens | Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
|
| |||||||||||||||||||||
| Second Intervention (1 Week) |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All eligible subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up. | All Eligible Dispensed Eyes | Posted | Mean | Standard Deviation | LogMAR | Dispensing Visit and 1 week follow-up | eyes | Participants |
|
1 week
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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 New Daily Disposable | New daily disposable contact lenses Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Steffen OD | 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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| Johnson & Johnson Acuvue Moist | Device | Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Slit Lamp Examination > Grade 2 | Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2. | All Dispensed Eyes | Posted | Number | Eyes | All study visits from screening through 2 week follow-up | eyes | Participants |
|
|
|
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Johnson & Johnson Acuvue Moist | Contact lenses Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis. | 0 | 102 | 0 | 102 |
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