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The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A MF, then AOAMF | Other | Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
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| AOAMF, then Delefilcon A MF | Other | Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A multifocal contact lenses | Device | Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use |
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| Measure | Description | Time Frame |
|---|---|---|
| High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | Dispense (Day 1), Hour 9 |
| Measure | Description | Time Frame |
|---|---|---|
| HC/HI Binocular VA at Distance | Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | Dispense (Day 1), Hour 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Nick, Dipl. Ing. | CIBA VISION GmbH | Study Director |
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Of the 36 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (34).
Subjects were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A MF, Then AOAMF | Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
| FG001 | AOAMF, Then Delefilcon A MF | Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 9 Hours of Wear |
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| Washout Period |
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| Period 2, Second 9 Hours of Wear |
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This analysis population includes all subjects/eyes exposed to any Investigational Product (IP) evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| 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 | High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria. | Posted | Mean | Standard Deviation | logMAR | Dispense (Day 1), Hour 9 |
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Adverse events (AEs) were collected from 04 Oct 2013 to 12 Nov 2013. This analysis group includes all subjects/eyes exposed to any Investigational Product (IP) evaluated in this study.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device.
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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 | Delefilcon A MF | Contact lenses worn during Period 1 or Period 2 for 9-12 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Fahmy, Head, Clinical Development, Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D006956 | Hyperopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Lotrafilcon B multifocal contact lenses | Device | Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement |
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| Over-refraction (OR) Monocular at Distance | OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean. | Dispense (Day 1), Hour 9 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Contact lenses worn during Period 1 or Period 2 for 9-12 hours |
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| Secondary | HC/HI Binocular VA at Distance | Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria. | Posted | Mean | Standard Deviation | logMAR | Dispense (Day 1), Hour 9 |
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| Secondary | Over-refraction (OR) Monocular at Distance | OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean. | This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria. | Posted | Mean | Standard Deviation | Diopters | Dispense (Day 1), Hour 9 | eyes | Participants |
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| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | AOAMF | Contact lenses worn during Period 1 or Period 2 for 9-12 hours | 0 | 34 | 0 | 34 |
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