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The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD118033 contact lens | Experimental | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. |
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| PureVision multifocal contact lens | Active Comparator | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LD118033 contact lens | Device | Multifocal contact lens worn on a daily wear basis for 1 week |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | At 1 week follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, PhD, MCOptom | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
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A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.
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| ID | Title | Description |
|---|---|---|
| FG000 | LD118033 Contact Lens Then PureVision Multifocal Contact Lens | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week |
| FG001 | PureVision Multifocal Contact Lens Then LD118033 Contact Lens | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Demography was collected for 124 eligible, dispensed participants. Participants received both treatment groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants/eyes received both treatment 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, 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 | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups. | Posted | Mean | Standard Deviation | logMAR | At 1 week follow up | eyes | eyes |
|
2 weeks
Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. A total of 126 participants (252 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study.
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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 | LD118033 Contact Lens | Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| PureVision multifocal contact lens | Device | PureVision multifocal contact lens worn on a daily wear basis for 1 week. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups. | Posted | Mean | Standard Deviation | score on a scale | At 1 week follow up | eyes | eyes |
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | PureVision Multifocal Contact Lens | PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. | 0 | 126 | 0 | 126 |
Contact sponsor directly for details.
| Comfort at end of day |
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| Overall comfort |
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| Dryness |
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| Itchiness |
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| Redness |
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| Distance Vision |
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| Vision at intermediate distance |
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| Vision at near distance |
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| Overall vision |
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| Ease of handling/insertion |
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| Ease of handling/removal |
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| Overall impression |
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