Visual Acuity
Conditions
Brief summary
This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.
Interventions
DEVICEAir Optix® Multifocal Contact Lenses Plus HydraGlyde®
CONTROL
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 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 (inclusive). 4. The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye. 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. 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 (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration). 10. The subject must either already 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.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating. 2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. 3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 4. 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. 5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions. 6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.). 7. A history of amblyopia, strabismus or binocular vision abnormality. 8. Any current ocular infection or inflammation. 9. Any current ocular abnormality that may interfere with contact lens wear. 10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 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 7 days prior to study enrollment. 14. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 15. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® multipurpose care solution, sodium fluorescein or single-use preservative free rewetting drop solution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Lens Centration | 6 to 8 days | Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported. |
| Percentage of Participants With Lens Movement | 6 to 8 days | Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Handling Scores | 6 to 8 days | 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, aged 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
Pre-assignment details
In total, 42 subjects were enrolled in this study; of which, 41 were randomly assigned into 2 sequences while, 1 subject failed to meet all eligibility criteria. Of the total assigned subjects, 40 subjects completed the study while, 1 subject was discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects dispensed a study lens. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Subject no longer meets the eligibility criteria | 1 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 51.2 Years STANDARD_DEVIATION 6.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment USA | 41 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Percentage of Participants With Lens Centration
Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.
Time frame: 6 to 8 days
Population: All subjects dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Percentage of Participants With Lens Centration | 97.3 Percentage of participants |
| Control | Percentage of Participants With Lens Centration | 91.9 Percentage of participants |
Comparison: The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions.95% CI: [0.33, 6.85]Generalized Linear Mixed Model Analysis
Primary
Percentage of Participants With Lens Movement
Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.
Time frame: 6 to 8 days
Population: All subjects dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Percentage of Participants With Lens Movement | 97.3 Percentage of participants |
| Control | Percentage of Participants With Lens Movement | 91.9 Percentage of participants |
Comparison: The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions.95% CI: [0.1, 1.19]Generalized Linear Mixed Model Analysis
Secondary
Overall Handling Scores
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, aged 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: 6 to 8 days
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Handling Scores | 60.3 CLUE points | Standard Deviation 19.02 |
| Control | Overall Handling Scores | 55.3 CLUE points | Standard Deviation 18.71 |
95% CI: [-12.48, 0.52]Mixed Model Analysis