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The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PureVision | Experimental | PureVision Contact Lens |
|
| Acuvue Oasys | Active Comparator | Acuvue Oasys Contact Lens |
|
| O2Optix | Active Comparator | O2Optix Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureVision Contact Lens | Device | contact lens for daily wear |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Any Slit Lamp Finding > Grade 2 | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured. | Over all follow-up visits for the 1 month study period |
| Subjective Responses to Comfort-related Symptoms/Complaints | Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. | Over all follow-up visits for 1 month study period |
| Uncorrected Distance High Contrast Visual Acuity | logMAR high contrast visual acuity (VA) over all visits. | Over all visits for the 1 month study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, MCOptom, PhD | Bausch & Lomb Incorporated | Study Director |
| Bruce Anderson, OD | Anderson & Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson & Associates | Tampa | Florida | 33612 | United States |
510 subjects (1020 eyes) were enrolled (all were dispensed). 477 subjects (954 eyes) completed the study. 10 subjects were ineligible at baseline and 23 were discontinued during the study.
546 subjects (1092 eyes) were planned to be enrolled at 26 investigative sites in the US. First subject enrolled on 2/25/2008 and last subject seen was 4/28/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | PureVision | Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis. |
| FG001 | Acuvue Oasys | Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis. |
| FG002 | O2Optix | Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PureVision | Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis. |
| BG001 | Acuvue Oasys | Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Any Slit Lamp Finding > Grade 2 | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured. | All dispensed eyes | Posted | Number | Eyes | Over all follow-up visits for the 1 month study period | eyes | Participants |
|
1 month
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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 | PureVision | Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Cairns | Bausch & Lomb Incorporated | (585) 338-5170 | gerard.cairns@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Acuvue Oasys Contact Lens |
| Device |
contact lens for daily wear |
|
| O2Optix Contact lens | Device | contact lens for daily wear |
|
| Study Related Symptoms/Complaints |
|
| Inability to Maintain Wearing Schedule |
|
| Failure to Follow Subject Instructions |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Unacceptable Lens Movement |
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| Poor fit/Uncomfortable |
|
| Ineligable at Baseline |
|
| Adverse event and positive slit lamp |
|
| BG002 | O2Optix | Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG002 | O2Optix | Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis. |
|
|
| Primary | Subjective Responses to Comfort-related Symptoms/Complaints | Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. | All eligible dispensed eyes. | Posted | Mean | Standard Deviation | Units on a Scale | Over all follow-up visits for 1 month study period | eyes | Participants |
|
|
|
| Primary | Uncorrected Distance High Contrast Visual Acuity | logMAR high contrast visual acuity (VA) over all visits. | All eligible dispensed eyes. | Posted | Apr 2009 | Mean | Standard Deviation | LogMAR | Over all visits for the 1 month study period | eyes | Participants |
|
|
|
| 0 |
| 340 |
| 0 |
| 340 |
| EG001 | Acuvue Oasys | Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis. | 0 | 340 | 0 | 340 |
| EG002 | O2Optix | Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis. | 0 | 340 | 0 | 340 |
The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
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| End of Day Comfort |
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| Lens Awareness |
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| Irritation |
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| Itching |
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| Dryness |
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| Redness |
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