Presbyopia, Refractive Error
Conditions
Keywords
DACP MF, DAILIES AquaComfort Plus® Multifocal, presbyopia, visual performance
Brief summary
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
Detailed description
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.
Interventions
DEVICENelfilcon A MF contact lenses (DACP MF)
Multifocal contact lenses in Low, Medium, High Add
DEVICENelfilcon A single vision contact lenses (DACP)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
41 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week * Spectacle add between +1.50 and +2.50 diopters (D) (inclusive) * Requiring lenses within the power range of both study contact lenses to be fitted * Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1 * Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance * Acceptable fit with both study contact lenses * Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Current multifocal contact lens wearer * Current monovision wearer or failed attempt with monovision * Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear * Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator * Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial * Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit * History of herpetic keratitis, ocular surgery or irregular cornea * Prior refractive surgery (e.g. LASIK, PRK, etc) * Monocular (only 1 eye with functional vision) or fit with only 1 lens * Habitually uncorrected anisometropia \>2.00D * Clinically significant anisocoria * Participation in any clinical trial within 30 days of the enrollment visit * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Day 5, each product | 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. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in Spain.
Pre-assignment details
Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).
Participants by arm
| Arm | Count |
|---|---|
| Overall DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 4.18 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: Day 5, each product
Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monovision | Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Near | 0.09 diopter*logMar |
| Monovision | Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Intermediate | 0.24 diopter*logMar |
| DACP MF | Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Near | 0.18 diopter*logMar |
| DACP MF | Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance | Intermediate | 0.36 diopter*logMar |