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The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Toric Lens | Experimental | Bausch + Lomb investigational toric contact lenses |
|
| PureVision Toric Lens | Active Comparator | Currently marketed Bausch + Lomb PureVision toric contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Toric Lens | Device | Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. | 2 weeks | |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Toric Lens Then PureVision Toric Lens | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
| FG001 | PureVision Toric Lens Then Investigational Toric Lens | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 151 participants were randomized to receive test contact lenses and 151 participants were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks. |
| 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 | Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. | There were 518 eyes in each group for this outcome measure. | Posted | Count of Units | eyes | 2 weeks | eyes | eyes |
|
4 weeks
Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 302 eyes dispensed each lens group, assessed for adverse events.
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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 | Investigational Toric Lens | Bausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 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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| PureVision Toric Lens | Device | Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. |
|
| 2 weeks |
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. | 2 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Primary | Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | There were 518 eyes in each group for this outcome measure. | Posted | Least Squares Mean | Standard Deviation | logMAR | 2 weeks | eyes | eyes |
|
|
|
| Secondary | Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression. | There were 571 eyes in each group assess for this outcome measure. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 2 weeks | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. | There were 600 eyes with non-missing scores in both groups for this outcome measure. | Posted | Count of Units | eyes | 2 weeks | eyes | eyes |
|
|
|
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | PureVision Toric Lens | Currently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks. | 0 | 151 | 0 | 151 |
Contact sponsor directly for details.
| Overall comfort |
|
| Comfort at the end of the day |
|
| Ease of handling/insertion |
|
| Ease of handling/removal |
|
| Dryness |
|
| Itchiness |
|
| Redness |
|
| Vision |
|
| Lens Cleanliness |
|
| Overall impression |
|