Visual Acuity
Conditions
Brief summary
This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear both Test and Control lenses in each eye in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
Interventions
DEVICE1-DAY ACUVUE® MOIST
etafilcon A contact lenses made with a new manufacturing technology
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
18 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. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening. 4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lenses in both eyes (at least 1 month of daily wear). 5. The subject must have normal eyes (i.e., no ocular medications or infections of any type). 6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye. 7. The subject's refractive cylinder must be \< 0.75D in each eye. 8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. 3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 4. Any ocular infection. 5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 6. Monovision or multi-focal contact lens correction. 7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 8. History of binocular vision abnormality or strabismus. 9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report). 10. Suspicion of or recent history of alcohol or substance abuse. 11. History of serious mental illness. 12. History of seizures. 13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician) 14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion 15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale 16. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Score | 1-Week Follow-up | Overall comfort score 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 (standard deviation \[SD\] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. |
| Overall Vision Score | 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. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LogMAR Visual Performance Scale | 1-Week follow-up | Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light. |
| Average Daily Wear Time | 1-Week follow-up | Average daily wear time was calculated as the number of hours between participants reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week follow-up evaluation. |
Countries
United States
Participant flow
Pre-assignment details
A total of 95 participants were enrolled in this study however one participant was never randomized due to screen failure therefore, 94 participants were randomized to receive study drug.
Participants by arm
| Arm | Count |
|---|---|
| Overall Set All subjects dispensed a study lens. | 94 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 0 | 1 |
| Period 1 | Failed to meet all eligibility criteria | 1 | 1 |
| Period 1 | No Longer Meets Eligibility Criteria | 1 | 0 |
| Period 1 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Set |
|---|---|
| Age, Continuous | 31.7 Years STANDARD_DEVIATION 9.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 6 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 | 78 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 91 |
| other Total, other adverse events | 0 / 93 | 0 / 90 |
| serious Total, serious adverse events | 0 / 93 | 0 / 90 |
Outcome results
Primary
Overall Comfort Score
Overall comfort score 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 (standard deviation \[SD\] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time frame: 1-Week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Test for Novel | Overall Comfort Score | 56.52 Units on a scale | Standard Deviation 20.631 |
| Etafilcon A Control for Current | Overall Comfort Score | 55.72 Units on a scale | Standard Deviation 22.567 |
Comparison: Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.95% CI: [-4.37, 4.65]
Primary
Overall Vision Score
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. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time frame: 1-Week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Test for Novel | Overall Vision Score | 61.65 Units on a scale | Standard Deviation 19.161 |
| Etafilcon A Control for Current | Overall Vision Score | 62.47 Units on a scale | Standard Deviation 20.67 |
Comparison: Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.95% CI: [-4.07, 2.06]
Secondary
Average Daily Wear Time
Average daily wear time was calculated as the number of hours between participants reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week follow-up evaluation.
Time frame: 1-Week follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Test for Novel | Average Daily Wear Time | 14.22 Hours | Standard Deviation 1.937 |
| Etafilcon A Control for Current | Average Daily Wear Time | 14.16 Hours | Standard Deviation 1.866 |
Comparison: Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.95% CI: [-0.32, 0.34]
Secondary
LogMAR Visual Performance Scale
Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light.
Time frame: 1-Week follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A Test for Novel | LogMAR Visual Performance Scale | High Contrast Dim | -0.018 logMAR units | Standard Deviation 0.1276 |
| Etafilcon A Test for Novel | LogMAR Visual Performance Scale | Low Contrast Bright | 0.022 logMAR units | Standard Deviation 0.0915 |
| Etafilcon A Control for Current | LogMAR Visual Performance Scale | High Contrast Dim | -0.017 logMAR units | Standard Deviation 0.1173 |
| Etafilcon A Control for Current | LogMAR Visual Performance Scale | Low Contrast Bright | 0.024 logMAR units | Standard Deviation 0.0924 |
Comparison: Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.95% CI: [-0.012, 0.01]
Comparison: Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.95% CI: [-0.014, 0.009]