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The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.
Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A MF, then AOAMF | Other | Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. |
|
| AOAMF, then Delefilcon A MF | Other | Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A multifocal contact lens | Device | Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular HC/HI Visual Acuity at Near (40 cm) | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity. | Up to Hour 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular HC/HI Visual Acuity at Distance | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Nick, Dipl.-Ing | Alcon Research | Study Director |
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Of the 42 participants enrolled, 1 participant was exited as a screen failure and 1 participant was discontinued due to product unavailability prior to study product exposure. This reporting group includes all enrolled participants exposed to study product (40).
Participants were recruited from 1 study center located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A MF, Then AOAMF | Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. |
| FG001 | AOAMF, Then Delefilcon A MF | Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 9 Hours |
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| Second 9 Hours |
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This reporting group includes all enrolled participants exposed to study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each. |
| 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 | Mean Binocular HC/HI Visual Acuity at Near (40 cm) | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity. | All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability. | Posted | Mean | Standard Deviation | logMAR | Up to Hour 9 |
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Adverse events were collected for the duration of the study (1 month). An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical sign whether or not related to the investigational medical device.
This reporting group includes all enrolled participants exposed to study product. Exposure to the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability.
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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 | Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Nick, Dipl.-Ing. (FH), Clinical Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Lotrafilcon B multifocal contact lens | Device | Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines |
|
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| Up to Hour 9 |
| Mean Monocular Over-refraction (OR) at Distance | OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean. | Up to Hour 9 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours |
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| Secondary | Mean Binocular HC/HI Visual Acuity at Distance | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity. | All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability. | Posted | Mean | Standard Deviation | logMAR | Up to Hour 9 |
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| Secondary | Mean Monocular Over-refraction (OR) at Distance | OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean. | All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability. | Posted | Mean | Standard Deviation | diopter | Up to Hour 9 |
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| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | AOAMF | Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours | 0 | 40 | 0 | 40 |
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