Visual Performance
Conditions
Brief summary
This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.
Interventions
Biotrue ONEday for Presbyopia Contact Lenses
Dailies Total 1 Multifocal Contact Lens
DEVICESpherical Contact Lens 2
BioTrue ONEDay Spherical
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be between at least 40 years of age and not greater than 70 years of age. 4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D. 5. The subject's refractive cylinder must be ≤ -0.75 D in each eye. 6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye. 7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. 8. The subject must own a pair of wearable spectacles if required for their distance vision. 9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration). 10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear. 2. Pregnancy or lactation. 3. Currently diagnosed with diabetes. 4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV). 5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. 6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions. 7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 8. A history of amblyopia, strabismus or binocular vision abnormality. 9. Any ocular infection or inflammation. 10. Any ocular abnormality that may interfere with contact lens wear. 11. Use of any ocular medication, with the exception of rewetting drops. 12. History of herpetic keratitis. 13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Binocular Visual Acuity | 1-Week Follow-up | Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. |
| Near Binocular Visual Acuity | 1-Week Follow-up | Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision | 1-Week Follow-up | Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
Countries
United States
Participant flow
Recruitment details
A total of 78 subjects were enrolled into this study. Of the enrolled all 78 were dispensed at least one study lens. Of the dispensed subjects 71 completed the study, while 7 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects that were dispensed a study lens. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Incorrect Lens Dispensed | 1 | 0 |
| Period 1 | Subject no longer eligible | 0 | 1 |
| Period 1 | Unsatisfactory Lens Fitting | 1 | 0 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
| Period 2 | Dispensed incorrect lens in left eye | 0 | 1 |
| Period 2 | Protocol Violation | 1 | 0 |
| Period 2 | Subject not eligible for Pytergiumectomy | 0 | 1 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 53.9 Years STANDARD_DEVIATION 7.27 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized White | 73 Participants |
| Region of Enrollment United States | 78 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 78 |
| other Total, other adverse events | 0 / 78 | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 | 0 / 78 |
Outcome results
Primary
Distance Binocular Visual Acuity
Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Time frame: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Distance Binocular Visual Acuity | -0.056 logMAR | Standard Deviation 0.0842 |
| Nesofilcon A | Distance Binocular Visual Acuity | -0.075 logMAR | Standard Deviation 0.0759 |
95% CI: [-0.08, -0.035]Linear mixed model analysis
95% CI: [-0.099, -0.054]Linear mixed model analysis
Primary
Near Binocular Visual Acuity
Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.
Time frame: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Near Binocular Visual Acuity | 0.143 logMAR | Standard Deviation 0.1084 |
| Nesofilcon A | Near Binocular Visual Acuity | 0.143 logMAR | Standard Deviation 0.1117 |
95% CI: [0.112, 0.17]Linear mixed model analysis
95% CI: [0.112, 0.17]Linear mixed model analysis
Secondary
Overall Quality of Vision
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 1-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Quality of Vision | 47.4 Units on a scale | Standard Deviation 17.81 |
| Nesofilcon A | Overall Quality of Vision | 49.3 Units on a scale | Standard Deviation 19.43 |
95% CI: [41.2, 49.9]Linear Mixed Model Analysis
95% CI: [42.1, 50.8]Linear Mixed Model Analysis