Presbyopia, Refractive Error
Conditions
Keywords
contact lenses, multifocal
Brief summary
The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.
Detailed description
Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.
Interventions
DEVICEDelefilcon A multifocal contact lens
Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written Informed Consent document. * Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses. * Be presbyopic with a spectacle add ≥ 0.50 diopter. * Currently wearing soft contact lenses at least 5 days a week. * Other protocol-specified inclusion criteria may apply
Exclusion criteria
* Eye injury or surgery within 12 weeks of enrollment in this trial. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in any clinical trial. * Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator. * Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator. * Binocular visual acuity worse than 20/25. * Corrected by monovision. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular HC/HI Visual Acuity at Near (40 cm) | Up to Hour 9 | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular HC/HI Visual Acuity at Distance | Up to Hour 9 | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity. |
| Mean Monocular Over-refraction (OR) at Distance | Up to Hour 9 | OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the United States.
Pre-assignment details
Of the 42 participants enrolled, 1 participant was exited as a screen failure and 1 participant was discontinued due to product unavailability prior to study product exposure. This reporting group includes all enrolled participants exposed to study product (40).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
Primary
Mean Binocular HC/HI Visual Acuity at Near (40 cm)
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
Time frame: Up to Hour 9
Population: All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | Mean Binocular HC/HI Visual Acuity at Near (40 cm) | Dispense (Hour 0) | 0.08 logMAR | Standard Deviation 0.1 |
| Delefilcon A MF | Mean Binocular HC/HI Visual Acuity at Near (40 cm) | Hour 9 | 0.05 logMAR | Standard Deviation 0.08 |
| AOAMF | Mean Binocular HC/HI Visual Acuity at Near (40 cm) | Dispense (Hour 0) | 0.06 logMAR | Standard Deviation 0.09 |
| AOAMF | Mean Binocular HC/HI Visual Acuity at Near (40 cm) | Hour 9 | 0.05 logMAR | Standard Deviation 0.1 |
Secondary
Mean Binocular HC/HI Visual Acuity at Distance
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Time frame: Up to Hour 9
Population: All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | Mean Binocular HC/HI Visual Acuity at Distance | Dispense (Hour 0) | -0.06 logMAR | Standard Deviation 0.04 |
| Delefilcon A MF | Mean Binocular HC/HI Visual Acuity at Distance | Hour 9 | -0.05 logMAR | Standard Deviation 0.08 |
| AOAMF | Mean Binocular HC/HI Visual Acuity at Distance | Dispense (Hour 0) | -0.06 logMAR | Standard Deviation 0.04 |
| AOAMF | Mean Binocular HC/HI Visual Acuity at Distance | Hour 9 | -0.05 logMAR | Standard Deviation 0.05 |
Secondary
Mean Monocular Over-refraction (OR) at Distance
OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.
Time frame: Up to Hour 9
Population: All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A MF | Mean Monocular Over-refraction (OR) at Distance | Dispense (Hour 0) | 0.08 diopter | Standard Deviation 0.14 |
| Delefilcon A MF | Mean Monocular Over-refraction (OR) at Distance | Hour 9 | 0.06 diopter | Standard Deviation 0.13 |
| AOAMF | Mean Monocular Over-refraction (OR) at Distance | Dispense (Hour 0) | 0.06 diopter | Standard Deviation 0.13 |
| AOAMF | Mean Monocular Over-refraction (OR) at Distance | Hour 9 | 0.03 diopter | Standard Deviation 0.12 |