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The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.
Two population groups (presbyopes and astigmats) will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1: Presbyopes | Other | Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. |
|
| Arm2: Astigmats | Other | Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A multifocal contact lenses | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. | Hour 12, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. |
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Inclusion Criteria:
Must sign an informed consent document;
Adapted, current soft contact lens wearer with either:
Contact lens prescription in the power range specified in the protocol;
Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
Willing to wear study lenses up to 12 hours and attend all study visits;
Can be successfully fitted with study lenses;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, Global Med Affairs, Operations | Alcon Research | Study Director |
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Of the 48 enrolled subjects, 3 were discontinued as screen failures prior to randomization. This reporting group includes all randomized subjects (45).
Subjects were recruited from 1 study center located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Presbyopes MF/Sphere | Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours. |
| FG001 | Presbyopes Sphere/MF | Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours. |
| FG002 | Astigmats Toric/Sphere | Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours. |
| FG003 | Astigmats Sphere/Toric | Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period |
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| Second Wear Period |
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| Third Wear Period |
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This analysis population includes all randomized and exposed subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Presbyopes | Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. |
| BG001 | Astigmats |
| 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 | Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. | This analysis population includes all randomized and exposed subjects with data at visit. | Posted | Number | percentage of subjects | Hour 12, each product |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 24 days). Ocular adverse events are presented for both study eye and non-study eye combined. AEs were reported as pre-treatment and treatment-emergent.
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.
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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 | All subjects who consented to participate in the study prior to the initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs, Brand Lead - Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Nelfilcon A toric contact lenses | Device |
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| Nelfilcon A sphere contact lenses | Device |
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| Hour 8, each product |
| Adverse Event |
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| Other prior to treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Presbyopes / Sphere | Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3 |
| OG002 | Astigmats / Toric | Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) |
| OG003 | Astigmats / Sphere | Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3 |
|
|
| Secondary | Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. | This analysis population includes all randomized and exposed subjects with data at visit. | Posted | Number | percentage of subjects | Hour 8, each product |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Presbyopes / Multifocal | All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized | 0 | 22 | 0 | 22 |
| EG002 | Presbyopes / Sphere First Exposure | All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized | 0 | 22 | 0 | 22 |
| EG003 | Presbyopes / Sphere Second Exposure | All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3 | 0 | 22 | 0 | 22 |
| EG004 | Astigmats / Toric | All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized | 0 | 21 | 0 | 21 |
| EG005 | Astigmats / Sphere First Exposure | All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized | 0 | 20 | 0 | 20 |
| EG006 | Astigmats / Sphere Second Exposure | All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3 | 0 | 20 | 0 | 20 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.