An interventional study of Nelfilcon A MF contact lenses (DACP MF) and Nelfilcon A single vision contact lenses (DACP) in Presbyopia and Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 41 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-11.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 24 is below the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
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Exclusion Criteria:
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).
Device: Nelfilcon A MF contact lenses (DACP MF) · Device: Nelfilcon A single vision contact lenses (DACP)
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).
Device: Nelfilcon A MF contact lenses (DACP MF) · Device: Nelfilcon A single vision contact lenses (DACP)
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).
Device: Nelfilcon A MF contact lenses (DACP MF) · Device: Nelfilcon A single vision contact lenses (DACP)
Multifocal contact lenses in Low, Medium, High Add
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.
Time frame: Day 5, each product
Subjects were recruited from 1 study center located in Spain.
| Milestone | Seq I | Seq 2 | Seq 3 | Seq 4 | Seq 5 | Seq 6 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Seq I | Seq 2 | Seq 3 | Seq 4 | Seq 5 | Seq 6 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Seq I | Seq 2 | Seq 3 | Seq 4 | Seq 5 | Seq 6 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| diopter*logMar | Monovision | DACP MF |
|---|---|---|
| Near | 0.09 | 0.18 |
| Intermediate | 0.24 | 0.36 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monovision | — | 0/24 (0%) | 0/24 (0%) |
| DACP MF | — | 0/24 (0%) | 0/24 (0%) |
| DACP MF (Low Add) | — | 0/24 (0%) | 0/24 (0%) |
This analysis population includes all subjects/eyes exposed to any investigational product evaluated in this study.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 50.8 ± 4.18 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 14 |
| Male | 10 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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