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The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redesigned Purevision Contact Lens | Experimental | Redesigned Bausch & Lomb PureVision contact lens |
|
| PureVision Contact Lens | Active Comparator | Bausch & Lomb PureVision contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redesigned Purevision Contact Lens | Device | Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | 1 month |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, MCOptom, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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There were 188 participants enrolled into each group, for a total of 376 participants enrolled. There were 185 participants in the redesigned group and 183 participants in the control group who were eligible and dispensed lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Redesigned Purevision Contact Lens | Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
| FG001 | PureVision Contact Lens | Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Redesigned Purevision Contact Lens | Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
| BG001 | PureVision Contact Lens |
| 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, 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 | Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated. | There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses. There were 368 dispensed eyes in the redesigned group and 360 dispensed eyes in the control group evaluable for the analysis population for the assessment of symptoms and complaints. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 1 month | eyes | eyes |
|
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Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 376 eyes dispensed the test lens and 376 eyes dispensed the control lens, 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 | Redesigned Purevision Contact Lens | Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| PureVision Contact Lens | Device | Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
|
| 1 month |
Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | PureVision Contact Lens | Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. |
|
|
| Secondary | Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses. | Posted | Mean | Standard Deviation | logMAR | 1 month | 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 188 participants (376 eyes) enrolled into each group, for a total of 376 participants enrolled (752 eyes). There were 372 eyes in the redesigned group and 374 eyes in the control group assessed for slit lamp findings during the study. | Posted | Count of Units | eyes | 1 month | eyes | eyes |
|
|
|
| 0 |
| 185 |
| 0 |
| 185 |
| EG001 | PureVision Contact Lens | Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month. | 0 | 183 | 0 | 183 |
Contact sponsor directly for details.