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The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
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| Comfilcon A /Lotrafilcon B | Other | Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens | Device | Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best. | One week of wear |
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Inclusion Criteria:
Exclusion Criteria:
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This reporting group includes all enrolled and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B / Comfilcon A | Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
| FG001 | Comfilcon A /Lotrafilcon B | Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Week of Wear |
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| Period 2, One Week of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | 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 Vision | Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best. | Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | One week of wear |
|
Adverse event data were collected for the duration of the trial: 19 days.
This reporting group includes all enrolled and exposed participants.
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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 | Lotrafilcon B | Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management | CIBA VISION | 1-678-415-3343 | Joseph.Rappon@cibavision.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Comfilcon A contact lens | Device | Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Comfilcon A | Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week. | 0 | 17 | 0 | 17 |
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