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The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP MF | Experimental | DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes). |
|
| DACP | Active Comparator | DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye). |
|
| DACP MF (Low Add) | Active Comparator | DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A MF contact lenses (DACP MF) | Device | Multifocal contact lenses in Low, Medium, High Add |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF. | Day 5, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, EMEA | Alcon Research | Study Director |
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Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).
Subjects were recruited from 1 study center located in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seq I | DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| FG001 | Seq 2 | DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| FG002 | Seq 3 | DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| FG003 | Seq 4 | DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| FG004 | Seq 5 | DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| FG005 | Seq 6 | DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 5 Days of Wear |
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| Period 2, Second 5 Days of Wear |
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| Period 3, Third 5 Days of Wear |
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This analysis population includes all subjects/eyes exposed to any investigational product evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF. | 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 | Number | diopter*logMar | Day 5, each product |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 19 days). This analysis group includes all subjects exposed to any investigational product evaluated in this study, 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 medical device. AEs were reported by the subject or observed by the investigator.
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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 | Monovision | Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Global Brand Lead, GCRA, Vision Care | Alcon Research, Ltd. | 1-888-451-3937 |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Nelfilcon A single vision contact lenses (DACP) | Device |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Monovision |
Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days. |
| OG001 | DACP MF | Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days. |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | DACP MF | Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days. | 0 | 24 | 0 | 24 |
| EG002 | DACP MF (Low Add) | Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days. | 0 | 24 | 0 | 24 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.