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This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PureVision Multi-Focal contact lenses | Experimental |
| |
| SofLens59 contact lens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureVision Multi-Focal contact lenses | Device | Contact lenses to be worn on a daily wear basis for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. | Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Eye Strain | Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always | 2 week visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly J Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
272 participants (544 eyes) were enrolled in the study, 7 participants were ineligible at baseline, 265 participants were eligible. 259 participants (518 eyes) completed the study.
This study was conducted at 25 sites, by 25 Investigators in the United States (US). First participant enrollment was 09/28/2009 and last participant exited the study 11/09/2009
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| ID | Title | Description |
|---|---|---|
| FG000 | PureVision Multi-Focal Contact Lenses | |
| FG001 | SofLens59 Contact Lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PureVision Multi-Focal Contact Lenses | |
| BG001 | SofLens59 Contact Lens | |
| BG002 | Total |
| 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 | Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. | Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses. | All Eligible, Dispensed Eyes with non-missing scores | Posted | Number | eyes | 2 weeks | eyes | Participants |
|
|
At each visit for 2 weeks
There were no adverse events reported during the study. There were no events requiring medical treatment related to the Test lens
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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 Multi-Focal Contact Lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Reindel, OD, MS | Bausch & Lomb Incorporated | (585) 338-8129 | william.t.reindel@bausch.com |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| SofLens59 contact lens | Device | Contact lenses to be worn on a daily wear basis for 2 weeks. |
|
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Study related symptoms & complaints |
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Total of all reporting groups
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| eyes |
|
|
| Secondary | Subjective Ratings of Eye Strain | Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always | All Eligible, Dispensed Eyes, CISS Composite Score | Posted | Mean | Standard Deviation | CISS Composite Score | 2 week visit |
|
|
|
| 0 |
| 270 |
| 0 |
| 270 |
| EG001 | SofLens59 Contact Lens | 0 | 274 | 0 | 274 |
Study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |