Visual Acuity
Conditions
Brief summary
3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.
Interventions
DEVICEetafilcon A
Investigational Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age. 4. 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 if not, respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire.(Appendix B). 5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study). 6. The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye. 7. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye. 8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye. 9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye. 10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye. 11. The subject must have a wearable pair of spectacles if required for their distance vision.
Exclusion criteria
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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | 12-16 Day Follow-up | Overall 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 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A With PVP All subject wore the etafilcon A with PVP lens throughout the entire duration of the study. | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Etafilcon A With PVP |
|---|---|
| Age, Continuous | 56.5 Years STANDARD_DEVIATION 6.65 |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized White | 61 Participants |
| Region of Enrollment United States | 63 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Primary
Overall Vision
Overall 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: 12-16 Day Follow-up
Population: Subjects that completed all visits without a major protocol deviation documented as impacted the assessment of the primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A With PVP | Overall Vision | 47.33 Units on a Scale | Standard Deviation 18.646 |
Comparison: It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).95% CI: [-4.6, 5.9]Linear mixed model (LMM)