Presbyopia
Conditions
Brief summary
The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
Interventions
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
DEVICElotrafilcon B single vision contact lens
Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
OTHEROver-reader spectacles
Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* has discontinued contact lens wear primarily due to age-related, near vision demands * requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction * has had an ocular examination in the last 2 years * Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction With the Lenses | 1 week of wear | Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study This reporting group includes all enrolled and dispensed subjects. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age Continuous | 48.3 years STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 12 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 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Overall Satisfaction With the Lenses
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Time frame: 1 week of wear
Population: Analysis conducted per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B Multifocal Contact Lens | Overall Satisfaction With the Lenses | 82.5 Units on a Scale | Standard Deviation 14.5 |
| Lotrafilcon B Single Vision Contact Lens + Reading Glasses | Overall Satisfaction With the Lenses | 64.4 Units on a Scale | Standard Deviation 22.9 |