Presbyopia
Conditions
Brief summary
The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.
Interventions
DEVICEbalafilcon A
multifocal contact lens
DEVICEsenofilcon A production
multifocal contact lens
DEVICEsenofilcon A test
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 respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.). * The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. * Refractive cylinder must be less than or equal to -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 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 a contagious immunosuppressive disease (e.g., HIV). * History of diabetes. History of binocular vision abnormality or strabismus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | 5 minutes after insertion | Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
| Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | 5 minutes after insertion | Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
| Type of Corneal Staining | after 1 week of lens wear, for each lens type | Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(\> or = to mm). |
| Overall Subjective Vision | after 1 week of lens wear, for each lens type | Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: 5 minutes after insertion
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Test | Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | 0.8191 logMAR | Standard Error 0.161 |
| Senofilcon A Prod | Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | 0.6942 logMAR | Standard Error 0.161 |
| Balafilcon A | Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | 1.0635 logMAR | Standard Error 0.161 |
Comparison: Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.97.5% CI: [-0.4143, 0.1644]Mixed Models Analysis
Comparison: Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.97.5% CI: [-0.6587, -0.07996]Mixed Models Analysis
Primary
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: 5 minutes after insertion
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Test | Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | -0.6735 logMAR | Standard Error 0.161 |
| Senofilcon A Prod | Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | -0.6327 logMAR | Standard Error 0.161 |
| Balafilcon A | Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | -0.1719 logMAR | Standard Error 0.161 |
Comparison: Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.97.5% CI: [-0.2485, 0.3302]Mixed Models Analysis
Comparison: Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.97.5% CI: [-0.7502, -0.1714]Mixed Models Analysis
Primary
Overall Subjective Vision
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time frame: after 1 week of lens wear, for each lens type
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Test | Overall Subjective Vision | 3.5373 Units on a scale | Standard Error 0.1681 |
| Senofilcon A Prod | Overall Subjective Vision | 3.207 Units on a scale | Standard Error 0.1681 |
| Balafilcon A | Overall Subjective Vision | 3.4351 Units on a scale | Standard Error 0.1681 |
Comparison: Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.97.5% CI: [-0.779, 0.1183]Mixed Models Analysis
Comparison: Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.97.5% CI: [-0.6767, 0.2206]Mixed Models Analysis
Primary
Type of Corneal Staining
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(\> or = to mm).
Time frame: after 1 week of lens wear, for each lens type
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Test | Type of Corneal Staining | 0.1311 Units on a scale | Standard Error 0.07154 |
| Senofilcon A Prod | Type of Corneal Staining | 0.1017 Units on a scale | Standard Error 0.07154 |
| Balafilcon A | Type of Corneal Staining | 0.1694 Units on a scale | Standard Error 0.07154 |
Comparison: Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.97.5% CI: [-0.08153, 0.02271]Mixed Models Analysis
Comparison: Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.97.5% CI: [-0.1198, -0.01553]Mixed Models Analysis