Hyperopia, Presbyopia, Refractive Error
Conditions
Keywords
contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia
Brief summary
The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
Interventions
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with normal eyes who are not using any ocular medication. * Must sign the Informed Consent document. * Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)). * Manifest cylinder less than or equal to 0.75D. * Best corrected distance VA greater than or equal to 20/25 in each eye. * Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week. * Presbyopic with a spectacle addition (ADD) \>0.50D and \<2.75D. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular disease, inflammation, or abnormality that contraindicates CL wear. * Any use of systemic or ocular medications for which CL wear could be contraindicated. * History of herpetic keratitis. * History of refractive surgery or irregular cornea. * A clinically significant dry eye that precludes CL wear. * Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days. * Monocular (only 1 eye with functional vision). * History of intolerance or hypersensitivity to any component of the test articles. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Dispense (Day 1), Hour 9 | Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HC/HI Binocular VA at Distance | Dispense (Day 1), Hour 9 | Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. |
| Over-refraction (OR) Monocular at Distance | Dispense (Day 1), Hour 9 | OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the US.
Pre-assignment details
Of the 36 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (34).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 |
Outcome results
Primary
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Time frame: Dispense (Day 1), Hour 9
Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Dispense | 0.10 logMAR | Standard Deviation 0.09 |
| Delefilcon A MF | High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Hour 9 | 0.08 logMAR | Standard Deviation 0.09 |
| AOAMF | High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Dispense | 0.12 logMAR | Standard Deviation 0.06 |
| AOAMF | High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Hour 9 | 0.09 logMAR | Standard Deviation 0.07 |
Secondary
HC/HI Binocular VA at Distance
Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Time frame: Dispense (Day 1), Hour 9
Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | HC/HI Binocular VA at Distance | Dispense | -0.02 logMAR | Standard Deviation 0.06 |
| Delefilcon A MF | HC/HI Binocular VA at Distance | Hour 9 | 0.00 logMAR | Standard Deviation 0.07 |
| AOAMF | HC/HI Binocular VA at Distance | Dispense | -0.03 logMAR | Standard Deviation 0.06 |
| AOAMF | HC/HI Binocular VA at Distance | Hour 9 | -0.01 logMAR | Standard Deviation 0.07 |
Secondary
Over-refraction (OR) Monocular at Distance
OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.
Time frame: Dispense (Day 1), Hour 9
Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | Over-refraction (OR) Monocular at Distance | Dispense | 0.00 Diopters | Standard Deviation 0 |
| Delefilcon A MF | Over-refraction (OR) Monocular at Distance | Hour 9 | 0.11 Diopters | Standard Deviation 0.16 |
| AOAMF | Over-refraction (OR) Monocular at Distance | Dispense | 0.00 Diopters | Standard Deviation 0 |
| AOAMF | Over-refraction (OR) Monocular at Distance | Hour 9 | 0.09 Diopters | Standard Deviation 0.14 |