Presbyopia, Refractive Error
Conditions
Keywords
contact lenses, lens centration, multifocal
Brief summary
The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
Detailed description
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
Interventions
Silicone hydrogel multifocal contact lenses for daily disposable wear
DEVICEEtafilcon A multifocal contact lenses
Hydrogel multifocal contact lenses for daily disposable wear
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sign informed consent * Habitually wear multifocal soft/ silicone hydrogel contact lenses * Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive) * Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance * Willing to wear contact lenses and attend all study visits
Exclusion criteria
* Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses * Any eye condition that would make contact lens wear unadvisable * Any use of medication that would make contact lens wear unadvisable * Prior refractive surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Investigator-graded Lens Centration of Optimal | Day 14, each product | Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 4 study sites located in Japan.
Pre-assignment details
Of the 151 enrolled, 17 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A multifocal contact lenses and etafilcon A multifocal contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 134 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, Second 14 Days of Wear | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 5.1 |
| Race/Ethnicity, Customized Japanese | 134 Participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 266 | 0 / 133 | 0 / 268 | 0 / 134 |
| other Total, other adverse events | 88 / 266 | 0 / 133 | 82 / 268 | 0 / 134 |
| serious Total, serious adverse events | 0 / 266 | 0 / 133 | 0 / 268 | 0 / 134 |
Outcome results
Primary
Percentage of Subjects With Investigator-graded Lens Centration of Optimal
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Time frame: Day 14, each product
Population: Full Analysis Set with data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DT1MF | Percentage of Subjects With Investigator-graded Lens Centration of Optimal | 97.0 percentage of subjects |
| AMMF | Percentage of Subjects With Investigator-graded Lens Centration of Optimal | 91.0 percentage of subjects |
p-value: 0.045595% CI: [0.2, 11.9]McNemar
p-value: 0.045595% CI: [0.2, 11.9]McNemar