Presbyopia
Conditions
Keywords
Contact lens, Presbyopia, Multifocal
Brief summary
The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
Interventions
DEVICELotrafilcon B multifocal contact lenses (new)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an Informed Consent document; * Presbyopic and require at least 2.25 diopters (D) spectacle ADD power; * Current or previous soft contact lens wearer; * Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) \[Early Treatment of Diabetic Retinopathy Study (ETDRS)\] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses; * Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial; * Manifest cylinder less than or equal to 1.00 D; * Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction); * 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, as determined by the investigator; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear; * Any history of herpetic keratitis; * History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia; * Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4); * Corneal vascularization that is mild (Grade 2) or higher; * A pathologically dry eye that precludes contact lens wear; * Monocular (only 1 eye with functional vision); * Anisometropia ≥ 1.50 D (contact lens distance prescription); * Clinically significant (\> 1 millimeter) anisocoria; * 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 within the previous 30 days; * Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment; * Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Visual Acuity (HCVA) Near Monocular | Day 1, 10 minutes after lens insertion, each product | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCVA Distance Monocular | Day 1, 10 minutes after lens insertion, each product | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. |
| HCVA Intermediate Monocular | Day 1, 10 minutes after lens insertion, each product | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. |
| Low Contrast Visual Acuity (LCVA) Distance Monocular | Day 1, 10 minutes after lens insertion, each product | Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 7 study centers located in the US.
Pre-assignment details
Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).
Participants by arm
| Arm | Count |
|---|---|
| Overall AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 107 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Lost to follow-up (prior to treatment) | 2 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 16 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 / 268 | 0 / 107 | 0 / 107 |
| serious Total, serious adverse events | 0 / 268 | 0 / 107 | 0 / 107 |
Outcome results
Primary
High Contrast Visual Acuity (HCVA) Near Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time frame: Day 1, 10 minutes after lens insertion, 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| New MF | High Contrast Visual Acuity (HCVA) Near Monocular | 0.18 logMAR | Standard Error 0.02 |
| AOAMF | High Contrast Visual Acuity (HCVA) Near Monocular | 0.32 logMAR | Standard Error 0.02 |
Secondary
HCVA Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time frame: Day 1, 10 minutes after lens insertion, 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| New MF | HCVA Distance Monocular | 0.11 logMAR | Standard Error 0.01 |
| AOAMF | HCVA Distance Monocular | 0.06 logMAR | Standard Error 0.01 |
Secondary
HCVA Intermediate Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time frame: Day 1, 10 minutes after lens insertion, 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| New MF | HCVA Intermediate Monocular | 0.04 logMAR | Standard Error 0.01 |
| AOAMF | HCVA Intermediate Monocular | 0.02 logMAR | Standard Error 0.01 |
Secondary
Low Contrast Visual Acuity (LCVA) Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time frame: Day 1, 10 minutes after lens insertion, 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| New MF | Low Contrast Visual Acuity (LCVA) Distance Monocular | 0.44 logMAR | Standard Error 0.01 |
| AOAMF | Low Contrast Visual Acuity (LCVA) Distance Monocular | 0.39 logMAR | Standard Error 0.01 |