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The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational contact lens | Experimental | multifocal high add soft contact lens |
|
| PureVision contact lens | Active Comparator | Multi-focal contact lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational contact lens | Device | Worn on a daily wear basis for one 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 2 weeks 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 2 weeks follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly J Barna, CCRA | 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 | Investigational Contact Lens Then PureVision Contact Lens | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week |
| FG001 | PureVision Contact Lens | Multi-focal contact lens then Investigational Contact Lens PureVision contact lens: Worn on a daily wear basis for one week multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one 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 in this cross-over study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants received both treatment groups in this cross-over study. |
| 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 238 eyes assessed for visual acuity for this outcome measure. Participants/eyes received both treatment groups. | Posted | Mean | Standard Deviation | logMAR | At 2 weeks follow up | eye | eye |
|
2 weeks
Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. A total of 126 participants (262 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 | Investigational Contact Lens | multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. Investigational contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one 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 contact lens | Device | Worn on a daily wear basis for one 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 238 eyes assessed for symptoms/complaints for this outcome measure. Participants/eyes received both treatment groups. | Posted | Mean | Standard Deviation | score on a scale | At 2 weeks follow up | eyes | eyes |
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | PureVision Contact Lens | Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week PureVision contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week. PureVision contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one 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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