Visual Acuity
Conditions
Brief summary
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
Interventions
DEVICEsenofilcon A
A soft spherical contact lens
DEVICElotrafilcon B
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or females that are at least 18 to no more than 40 years of age. 2. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. 3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision. 5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years). 6. The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes. 7. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis). 8. The subject must have corrected visual acuity of 20/20 or better in each eye.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye. 5. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) 6. Current wearers of rigid or hybrid contact lenses. 7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. 8. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). 9. History of binocular vision abnormality or strabismus. 10. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician). 11. Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements. 12. Strabismus, suppression or amblyopia. 13. Any ocular infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | 2 hours post insertion | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. |
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | 2 hours post insertion | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. |
| Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | 2 hours post insertion | Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. |
Countries
Australia
Participant flow
Pre-assignment details
A total of 25 subjects were enrolled into this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 21 were dispensed study lenses. Of the dispensed subjects all 21 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed All subjects that were dispensed at least 1 study lens during the course of the study. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Dispensed |
|---|---|
| Age, Continuous | 23.1 years STANDARD_DEVIATION 5.43 |
| Race/Ethnicity, Customized Asian | 14 participants |
| Race/Ethnicity, Customized White | 7 participants |
| Region of Enrollment Australia | 21 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Time frame: 2 hours post insertion
Population: All subjects that have completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | 0.125 microns | Standard Deviation 0.0559 |
| Lotrafilcon B | Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | 0.132 microns | Standard Deviation 0.0511 |
Primary
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Time frame: 2 hours post insertion
Population: All subjects that have completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | 0.165 microns | Standard Deviation 0.0857 |
| Lotrafilcon B | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | 0.146 microns | Standard Deviation 0.0567 |
Primary
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Time frame: 2 hours post insertion
Population: All subjects that have completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | 0.159 microns | Standard Deviation 0.0662 |
| Lotrafilcon B | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | 0.142 microns | Standard Deviation 0.0605 |