Myopia, Presbyopia
Conditions
Keywords
Myopia, Presbyopia
Brief summary
The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.
Interventions
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
DEVICEComfilcon A contact lens
Commercially marketed (France), 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. * Spectacle add of +0.50 to +2.50 diopters (inclusive). * Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day. * Able to be fit in both eyes with soft multifocal lenses in available powers. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within 12 weeks of enrollment in trial. * Currently enrolled in any clinical trial. * Astigmatism of 1.00 diopter or more. * Currently wearing excluded brands of multifocal lenses, as specified by protocol. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | 1 week | 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 equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. |
| Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | 1 week | 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 equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. |
Participant flow
Recruitment details
Participants were recruited and enrolled from 12 US private practices.
Pre-assignment details
Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.
Participants by arm
| Arm | Count |
|---|---|
| Overall All enrolled and dispensed participants | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period One: One Week | Lost to Follow-up | 0 | 1 |
| Period Two: One Week | Lost to Follow-up | 0 | 1 |
| Period Two: One Week | Time/job conflict | 0 | 1 |
| Period Two: One Week | Unacceptable Objective Visual Acuity | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 49.0 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States | 104 participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 104 |
| serious Total, serious adverse events | 0 / 103 | 0 / 104 |
Outcome results
Primary
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
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 equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time frame: 1 week
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| 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 |
| Comfilcon A | Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | 0.00 logMAR | Standard Deviation 0.06 |
Primary
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
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 equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time frame: 1 week
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | 0.12 logMAR | Standard Deviation 0.1 |
| Comfilcon A | Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | 0.10 logMAR | Standard Deviation 0.12 |