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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal CL / Single vision CL + reading glasses | Other | Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
|
| Single vision CL + reading glasses / Multifocal CL | Other | Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lotrafilcon B multifocal contact lens | Device | Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Satisfaction With the Lenses | Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied. | 1 week of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal CL / Single Vision CL+ Reading Glasses | Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
| FG001 | Single Vision CL + Reading Glasses / Multifocal CL | Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Week of Wear |
| |||||||||||||
| Period 2, One Week of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This reporting group includes all enrolled and dispensed subjects. |
| 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 | Overall Satisfaction With the Lenses | Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied. | Analysis conducted per protocol | Posted | Mean | Standard Deviation | Units on a Scale | 1 week of wear |
|
Adverse event data were collected for the duration of the trial. Individual subject exposure = 1 week per product, total 2 weeks.
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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 | Multifocal Contact Lens | Commercially marketed lotrafilcon B multifocal contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs | CIBA VISION | 1-800-241-7629 | priya.janakiraman@cibavision.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B single vision contact lens | Device | Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use |
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| Over-reader spectacles | Other | Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Single Vision Contact Lens | Commercially marketed lotrafilcon B single vision contact lenses | 0 | 16 | 0 | 16 |
No distribution of trial-specific information without express written permission of director.