Myopia
Conditions
Brief summary
To evaluate the clinical performance of daily disposable etafilcon A lenses.
Interventions
DEVICEetafilcon A
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
No
Inclusion criteria
* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must be at least 18 and not more than 70 years of age. * The subject's refractive cylinder must be \< 1.00 Diopters (D) in each eye. * The subject must have best corrected visual acuity of 20/25 or better in each eye. * The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye. * The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes. * The subject must self-report their race as Asian * The subject must have normal eyes (i.e., no ocular medications or infections of any type). * The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.
Exclusion criteria
* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). * Any ocular or systemic allergies or diseases that may interfere with contact lens wear. * Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia. * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.). * Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Monovision or multi-focal contact lens correction. * Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. * History of binocular vision abnormality or strabismus. * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report). * Suspicion of or recent history of alcohol or substance abuse. * History of serious mental illness. * History of seizures. * Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 1-week follow-up | Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. |
| Overall Vision | 1- week Follow-up | Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. |
| Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim | 1-week follow-up | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. |
| Monocular logMar Visual Acuity - Standard Low Contrast Bright | 1- week Follow-up | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. |
Countries
United States
Participant flow
Pre-assignment details
128 of the 136 subjects were randomized. 8 subjects did not meet the eligibility criteria. 3 subjects were discontinued from the study. 12 subjects were excluded from analysis due to major protocol deviations. 113 subjects completed all study visits without a major protocol deviation.
Participants by arm
| Arm | Count |
|---|---|
| Control/Test Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A. | 66 |
| Test/Control Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A | 62 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Protocol Violation | 1 | 0 |
| Period 1 | Withdrawal by Subject | 1 | 0 |
| Period 2 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Control/Test | Total | Test/Control |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 9.02 | 31.0 years STANDARD_DEVIATION 8.29 | 30.6 years STANDARD_DEVIATION 7.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 66 Participants | 128 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 66 participants | 128 participants | 62 participants |
| Sex: Female, Male Female | 52 Participants | 103 Participants | 51 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 113 | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 |
Outcome results
Primary
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Time frame: 1-week follow-up
Population: Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim | 0.030 LogMar | Standard Deviation 0.088 |
| Test | Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim | 0.020 LogMar | Standard Deviation 0.085 |
Primary
Monocular logMar Visual Acuity - Standard Low Contrast Bright
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Time frame: 1- week Follow-up
Population: Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Monocular logMar Visual Acuity - Standard Low Contrast Bright | 0.060 LogMar | Standard Deviation 0.083 |
| Test | Monocular logMar Visual Acuity - Standard Low Contrast Bright | 0.050 LogMar | Standard Deviation 0.079 |
Primary
Overall Comfort
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Time frame: 1-week follow-up
Population: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Overall Comfort | 60.1 units on a scale | Standard Deviation 18.47 |
| Test | Overall Comfort | 43.6 units on a scale | Standard Deviation 20.19 |
Primary
Overall Vision
Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Time frame: 1- week Follow-up
Population: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Overall Vision | 64.9 units on a scale | Standard Deviation 18.23 |
| Test | Overall Vision | 58.0 units on a scale | Standard Deviation 19.51 |