Ametropia, Myopia, Presbyopia, Refractive Error
Conditions
Keywords
Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal
Brief summary
The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.
Interventions
DEVICENelfilcon A multifocal contact lens with comfort additive
DEVICENelfilcon A multifocal contact lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent Document. * Presbyopic and require a spectacle add of up to and including 3.00 diopters (D). * Currently wear soft contact lenses. * Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule. * Manifest cylinder less than or equal to 1.00 D. * Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction). * Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated. * History of corneal or refractive surgery. * Biomicroscopy findings greater than Grade 2 at baseline. * A pathologically dry eye that precludes contact lens wear. * Monocular (only one eye with functional vision). * Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis). * History of intolerance or hypersensitivity to any component of the investigational products. * Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days. * Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Vision | Up to Day 30 | The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | Up to Day 30 | Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. |
| Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | Up to Day 30 | Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity. |
Participant flow
Recruitment details
Participants were recruited from 9 study centers located in the United States.
Pre-assignment details
Of the 83 consented participants, 2 were exited as screen failures prior to randomization, and 2 were exited after randomization but prior to product dispense. This reporting group includes all randomized participants who were dispensed study product (79).
Participants by arm
| Arm | Count |
|---|---|
| DAILIES® AquaComfort Plus® Multifocal Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis | 52 |
| Focus® DAILIES® Progressives Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | 27 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | DAILIES® AquaComfort Plus® Multifocal | Focus® DAILIES® Progressives | Total |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 5.19 | 49.7 years STANDARD_DEVIATION 5.21 | 49.8 years STANDARD_DEVIATION 5.16 |
| Sex: Female, Male Female | 34 Participants | 22 Participants | 56 Participants |
| Sex: Female, Male Male | 18 Participants | 5 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 27 |
| serious Total, serious adverse events | 0 / 52 | 0 / 27 |
Outcome results
Primary
Subjective Overall Vision
The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
Time frame: Up to Day 30
Population: This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm.~group,
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Multifocal | Subjective Overall Vision | Dispense (Day 0) (n=49,26) | 8.7 Units on a scale | Standard Deviation 1.1 |
| DAILIES® AquaComfort Plus® Multifocal | Subjective Overall Vision | Day 14 (n=50,26) | 8.6 Units on a scale | Standard Deviation 1.2 |
| DAILIES® AquaComfort Plus® Multifocal | Subjective Overall Vision | Day 3 (n=49,26) | 8.4 Units on a scale | Standard Deviation 1.3 |
| DAILIES® AquaComfort Plus® Multifocal | Subjective Overall Vision | Day 30 (n=50,26) | 8.5 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Progressives | Subjective Overall Vision | Day 3 (n=49,26) | 7.5 Units on a scale | Standard Deviation 1.7 |
| Focus® DAILIES® Progressives | Subjective Overall Vision | Day 30 (n=50,26) | 7.6 Units on a scale | Standard Deviation 1.9 |
| Focus® DAILIES® Progressives | Subjective Overall Vision | Dispense (Day 0) (n=49,26) | 8.4 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Progressives | Subjective Overall Vision | Day 14 (n=50,26) | 7.7 Units on a scale | Standard Deviation 1.9 |
Secondary
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
Time frame: Up to Day 30
Population: This analysis population includes all randomized and dispensed participants who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 40 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 5 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 5 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 4 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 8 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 38 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 4 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 40 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 6 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 42 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 6 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 2 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 22 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 4 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 1 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 0 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 24 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 1 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 1 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 4 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 21 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/30 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/15 | 2 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/20 | 19 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses | 20/25 | 5 participants |
Secondary
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
Time frame: Up to Day 30
Population: This reporting group includes all randomized and dispensed participants who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 21 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 19 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 0 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 1 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 0 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 1 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 6 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 2 participants |
| DAILIES® AquaComfort Plus® Multifocal | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 6 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 18 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 24 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 0 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 1 participants |
| Focus® DAILIES® Progressives | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 1 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 6 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 1 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 2 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 0 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 15 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 25 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| DACP MF @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 1 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 0 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 0 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 0 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 23 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 20 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 7 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 0 participants |
| DACP MF @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 1 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 1 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 0 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 3 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 7 participants |
| FDP @ Dispense | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 14 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 8 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 0 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 5 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 1 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 0 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 1 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 10 participants |
| FDP @ Day 3 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 1 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 2 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 10 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 2 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 5 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 1 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 1 participants |
| FDP @ Day 14 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 5 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/40 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/32 | 4 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/16 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/30 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/12.5 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/25 | 14 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/50 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/10 | 0 participants |
| FDP @ Day 30 | Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses | 20/20 | 8 participants |