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The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New MF, then AOAMF | Other | Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour. |
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| AOAMF, then New MF | Other | Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B multifocal contact lenses (new) | Device |
| ||
| Lotrafilcon B multifocal contact lenses |
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Visual Acuity (HCVA) Near Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | Day 1, 10 minutes after lens insertion, each product |
| Measure | Description | Time Frame |
|---|---|---|
| HCVA Distance Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | Day 1, 10 minutes after lens insertion, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, Vision Care, GCRA | Alcon Research | Study Director |
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Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).
Subjects were recruited from 7 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | New MF, Then AOAMF | Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour. |
| FG001 | AOAMF, Then New MF | Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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This analysis population includes all randomized and treated subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) 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 Visual Acuity (HCVA) Near Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP). | Posted | Least Squares Mean | Standard Error | logMAR | Day 1, 10 minutes after lens insertion, each product | Eyes | Participants |
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Adverse events (AEs) were collected for the duration of the study (3 months). AEs are reported as pre-treatment and treatment-emergent, based on treatment-specific exposure.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
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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 | Pre-treatment | Includes all enrolled subjects/eyes prior to exposure to the investigational products |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Vision Care, GCRA | Alcon Research, Ltd | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
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| HCVA Intermediate Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | Day 1, 10 minutes after lens insertion, each product |
| Low Contrast Visual Acuity (LCVA) Distance Monocular | Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | Day 1, 10 minutes after lens insertion, each product |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | AOAMF | Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour |
|
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| Secondary | HCVA Distance Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP). | Posted | Least Squares Mean | Standard Error | logMAR | Day 1, 10 minutes after lens insertion, each product | Eyes | Participants |
|
|
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| Secondary | HCVA Intermediate Monocular | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP). | Posted | Least Squares Mean | Standard Error | logMAR | Day 1, 10 minutes after lens insertion, each product | Eyes | Participants |
|
|
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| Secondary | Low Contrast Visual Acuity (LCVA) Distance Monocular | Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. | This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP). | Posted | Least Squares Mean | Standard Error | logMAR | Day 1, 10 minutes after lens insertion, each product | Eyes | Participants |
|
|
|
| 0 |
| 268 |
| 0 |
| 268 |
| EG001 | New MF | Includes all subjects/eyes exposed to New MF | 0 | 107 | 0 | 107 |
| EG002 | AOAMF | Includes all subjects/eyes exposed to AOAMF | 0 | 107 | 0 | 107 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.