Visual Acuity
Conditions
Brief summary
This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.
Interventions
DEVICEetafilcon A Investigational Toric Multifocal Contact Lens
Test Lens 1
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 40 and 70 years of age. 4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D. 5. The subject's refractive cylinder must be -1.00 to -1.50 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. Subjects must own a wearable pair of spectacles if required for their distance vision 9. The subject must be an adapted soft contact lens wearer in both eyes (ie, 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 already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the Presbyopic Systems Questionnaire.
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 (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, 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 (eg, 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 (eg, Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Handling Comparison Between Test 1/Test 2 and Control | 15 minutes | Overall handling 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Handling Comparison Between Test 3/Test 4 and Control | 15 minutes | Overall handling 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 96 subjects were enrolled in this study, of which 91 subjects were assigned at least 1 study lens, 5 subjects failed to meet all eligibility criteria. Of the total assigned subjects, 88 completed the study, while 3 were discontinued.
Pre-assignment details
Subjects were randomized to 1 of 10 unique lens sequences.
Participants by arm
| Arm | Count |
|---|---|
| Completed Subjects All subjects who were administered study article and completed all required study visits. | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 3 | Unsatisfactory Test Article | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period 4 | Unsatisfactory Test Article | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Completed Subjects |
|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 7.59 |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 73 Participants |
| Region of Enrollment United States | 88 Participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 | 0 / 90 | 0 / 89 | 0 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 | 0 / 90 | 0 / 89 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 | 0 / 90 | 0 / 89 | 0 / 90 |
Outcome results
Primary
Overall Handling Comparison Between Test 1/Test 2 and Control
Overall handling 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: 15 minutes
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 | Overall Handling Comparison Between Test 1/Test 2 and Control | 57.1 units on a scale | Standard Deviation 21.34 |
| Test 2 | Overall Handling Comparison Between Test 1/Test 2 and Control | 53.3 units on a scale | Standard Deviation 22.47 |
| Control | Overall Handling Comparison Between Test 1/Test 2 and Control | 52.3 units on a scale | Standard Deviation 23.88 |
95% CI: [0.1, 11.6]Mixed Models Analysis
95% CI: [-4, 8.1]Mixed Models Analysis
Secondary
Overall Handling Comparison Between Test 3/Test 4 and Control
Overall handling 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: 15 minutes
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 | Overall Handling Comparison Between Test 3/Test 4 and Control | 50.7 units on a scale | Standard Deviation 22.59 |
| Test 2 | Overall Handling Comparison Between Test 3/Test 4 and Control | 49.1 units on a scale | Standard Deviation 22.83 |
| Control | Overall Handling Comparison Between Test 3/Test 4 and Control | 52.3 units on a scale | Standard Deviation 23.88 |
95% CI: [-7.5, 4.6]Mixed Models Analysis
95% CI: [-9, 2.3]Mixed Models Analysis