Presbyopia
Conditions
Brief summary
The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.
Interventions
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
DEVICEComfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, 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
* At least 35 years of age. * Sign written Informed Consent * Spectacle add of +0.50 to +2.50D. * Best corrected visual acuity of at least 20.30 in both eyes. * Currently wearing soft contact lenses at least 5 days per week. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks of enrollment. * Currently enrolled in any clinical trial. * Astigmatism \> 1.00D. * Strabismus/amblyopia. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | One week of wear | Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best. |
Participant flow
Pre-assignment details
This reporting group includes all enrolled and dispensed participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed subjects. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, One Week of Wear | Unacceptable subjective vision | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 48.6 years STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 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 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Overall Vision
Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.
Time frame: One week of wear
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Overall Vision | 8.5 units on a scale | Standard Deviation 1.2 |
| Comfilcon A | Overall Vision | 8.3 units on a scale | Standard Deviation 1.1 |