Presbyopia
Conditions
Brief summary
The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.
Interventions
Silicone hydrogel, soft, multifocal contact lens for daily wear use
DEVICEOmafilcon A multifocal contact lens
Hydrogel, soft, multifocal contact lens for daily wear use
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 35 years of age. * Best-corrected visual acuity of at least 20/40 in each eye. * Spectacle add from +1.50D and +2.50D (inclusive). * Able to be fit in available study sphere powers (Plano to -4.00D). * Currently wearing soft contact lenses at least 5 days a week. * Other protocol inclusion /
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | After 1 week of wear | Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity. |
Participant flow
Pre-assignment details
Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed subjects. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Did not meet inclusion criteria | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 49.3 years STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 45 |
| serious Total, serious adverse events | 0 / 46 | 0 / 45 |
Outcome results
Primary
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Time frame: After 1 week of wear
Population: Per Protocol. Analysis excluded major protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | 0.00 logMAR | Standard Deviation 0.07 |
| Omafilcon A | Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | -0.02 logMAR | Standard Deviation 0.06 |