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The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP MF, then PROCLEAR 1D MF | Other | DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
|
| PROCLEAR 1D MF, then DACP MF | Other | PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DACP MF | Device | Nelfilcon A multifocal contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear | Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception. | Day 5, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | 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. Trial 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager | Alcon, Spain | Study Director |
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This reporting group includes all enrolled participants (70).
Participants were recruited from one investigational center located in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP MF, Then PROCLEAR 1D MF | Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
| FG001 | PROCLEAR 1D MF, Then DACP MF | Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment Period |
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| Period 1 (5 Days) |
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| Period 2 (5 Days) |
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Intention to treat, defined as the set of all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | DACP MF, Then PROCLEAR 1D MF | Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. |
| BG001 | PROCLEAR 1D MF, Then DACP MF | Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. |
| 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 Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear | Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | arcsec | Day 5, each product |
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Adverse events (AEs) were collected for the duration of the study from the time of first lens fitting, throughout 10 days (+/- 2 days) of lens wear.
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.
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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 | Proclear 1 Day MF | Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs Franchise Head, Vision Care | 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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| PROCLEAR 1D MF | Device | Omafilcon A multifocal contact lenses |
|
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| Day 5, each product |
| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | 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. Trial 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. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | diopter*logMar | Day 5, each product |
|
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| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | DACP MF | Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2. | 0 | 69 | 0 | 69 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.