Presbyopia
Conditions
Brief summary
The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.
Interventions
DEVICEbalafilcon A
multifocal contact lens
DEVICEsenofilcon A
multifocal contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The subject must between 35 and 70 years of age. * The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction. * The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye. * Refractive cylinder must be -0.75 D in each eye. * The subject must have an ADD power of +0.75D to +2.50D in each eye. * The subject must have best corrected visual acuity of 20/20-3 or better in each eye * The subject's must have at least 20/30-distance vision OU with the study contact lenses. * The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses * The subject must be an adapted soft contact lens wearer in both eyes. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
Exclusion criteria
* Ocular or systemic allergies or disease that may interfere with contact lens wear. * Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear. * Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear * Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Pregnancy or lactation * Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * History of diabetes * History of binocular vision abnormality or strabismus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity | after 1 week of wear | This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal |
| Near Visual Acuity | after 1 week wear | This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal. |
| Subject Vision | after 1 week wear | Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 1 |
| Period 1 | Lost to Follow-up | 1 | 0 |
| Period 1 | non-compliance | 1 | 0 |
| Period 2 | lens comfort issue | 3 | 0 |
| Period 2 | lens physiology issue | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 55 |
| serious Total, serious adverse events | 0 / 58 | 0 / 55 |
Outcome results
Primary
Distance Visual Acuity
This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal
Time frame: after 1 week of wear
Population: Analysis includes participants who completed the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Distance Visual Acuity | -0.08591 logMAR units | Standard Error 0.008816 |
| Balafilcon A | Distance Visual Acuity | -0.10267 logMAR units | Standard Error 0.008855 |
Comparison: Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.95% CI: [-0.08591, -0.06857]Mixed Models Analysis
Primary
Near Visual Acuity
This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal.
Time frame: after 1 week wear
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Near Visual Acuity | 0.02711 logMAR units | Standard Error 0.008816 |
| Balafilcon A | Near Visual Acuity | 0.01933 logMAR units | Standard Error 0.008861 |
Comparison: Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.97.5% CI: [0.02711, 0.04445]Mixed Models Analysis
Primary
Subject Vision
Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Time frame: after 1 week wear
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subject Vision | 3.4594 Scores on a scale | Standard Error 0.09926 |
| Balafilcon A | Subject Vision | 3.3853 Scores on a scale | Standard Error 0.09926 |
Comparison: Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.97.5% CI: [-0.1797, 0.07407]Mixed Models Analysis