Visual Acuity
Conditions
Brief summary
This is a multi-site, prospective, randomized, controlled, double-masked, four-arm-parallel-group, dispensing study. Each subject will be bilaterally fitted with one of four types of test articles and wear contact lenses of the assigned lens type during the entire course of the study. Test articles will be worn a minimum 8 hours per day and 5 days per week (subjects will be encouraged to wear study contact lenses 10 hours or more per day and 7 days per week) in a daily disposable modality for a minimum of 6 months and up to 1 year for a total of 7 scheduled visits.
Interventions
DEVICEEMO-114
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICEEMO-116
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICEEMO-118
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICEEMO-117
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 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 (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form. 2. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form. 3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. Between 7 and 12 years of age (inclusive). 5. Have normal eyes (i.e., no ocular medications or infections of any type). 6. Distance subjective best-sphere refraction must be between -0.75D and -4.50D (inclusive) in each eye. 7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction. 8. Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 0.8 in decimal convention or 0.10 logMAR) or better in each eye. 9. Cycloplegic objective sphero-cylindrical refraction (by auto refraction) must be between -0.75D and -4.50D in sphere and is 1.00D or less in cylinder in each eye (based on the average of 5 repeated sphero-cylindrical refraction measures). 10. The difference in spherical equivalent power between the two eyes must be less than 1.50D (based on the average of 5 repeated sphero-cylindrical refraction measures).
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 systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other systemic diseases (e.g., diabetes), by the parent or legal guardian's report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. 4. Any current use of ocular topical medication. 5. Any previous or planned ocular or intraocular surgery, including refractive surgery. 6. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 7. Participation in any prior myopia control clinical study in the test group. 8. Current or recent (within 30 days from enrollment) rigid lens wearers. 9. History of orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal contact or spectacle lenses) or drugs (e.g., atropine or pirenzepine) for the purpose of controlling myopia progression. 10. Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved equivalent) Rewetting Drop Solution. 11. Relatives of employee of investigational clinic (e.g., Investigator, Coordinator, Technician). 12. 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, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes. 13. Grade 3 or greater palpebral conjunctival observations or any other grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale. 14. 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. 15. Any central corneal scar 16. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear. 17. Binocular vision abnormality, intermittent strabismus or strabismus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | 6-month follow-up | Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique. |
| Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | 6-month follow-up | SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor. |
Countries
China
Participant flow
Recruitment details
A total of 240 subjects were enrolled into this study. Of those enrolled, 199 subjects were randomized and dispensed one of the four study lenses while 41 subjects failed too meet all eligibility criteria. Of those dispensed, 14 subjects discontinued and 185 subjects completed all required study visits.
Participants by arm
| Arm | Count |
|---|---|
| Test 1 Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study | 50 |
| Test 2 Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study | 48 |
| Test 3 Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study | 50 |
| Control Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study | 51 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Lens Discomfort | 0 | 1 | 0 | 0 |
| Overall Study | Lens Handling Difficulties | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Subject Decided to Not Wear Contact Lenses | 0 | 0 | 0 | 3 |
| Overall Study | Subject No Longer Meets Eligibility Criteria | 1 | 0 | 0 | 0 |
| Overall Study | Unsatisfactory Visual Response due to Test Article | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 3 | 0 |
Baseline characteristics
| Characteristic | Test 1 | Total | Control | Test 3 | Test 2 |
|---|---|---|---|---|---|
| Age, Continuous | 10.1 years STANDARD_DEVIATION 1.38 | 10.0 years STANDARD_DEVIATION 1.51 | 9.9 years STANDARD_DEVIATION 1.59 | 10.0 years STANDARD_DEVIATION 1.58 | 10.2 years STANDARD_DEVIATION 1.51 |
| Race/Ethnicity, Customized Asian | 26 Count of Participants | 102 Count of Participants | 24 Count of Participants | 27 Count of Participants | 25 Count of Participants |
| Race/Ethnicity, Customized Black or African American | 0 Count of Participants | 5 Count of Participants | 2 Count of Participants | 2 Count of Participants | 1 Count of Participants |
| Race/Ethnicity, Customized Other | 2 Count of Participants | 6 Count of Participants | 0 Count of Participants | 2 Count of Participants | 2 Count of Participants |
| Race/Ethnicity, Customized White | 22 Count of Participants | 86 Count of Participants | 25 Count of Participants | 19 Count of Participants | 20 Count of Participants |
| Region of Enrollment Canada | 5 Participants | 17 Participants | 4 Participants | 5 Participants | 3 Participants |
| Region of Enrollment China | 25 Participants | 97 Participants | 23 Participants | 25 Participants | 24 Participants |
| Region of Enrollment United States | 20 Participants | 85 Participants | 24 Participants | 20 Participants | 21 Participants |
| Sex: Female, Male Female | 28 Participants | 106 Participants | 25 Participants | 24 Participants | 29 Participants |
| Sex: Female, Male Male | 22 Participants | 93 Participants | 26 Participants | 26 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 48 | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 9 / 50 | 4 / 48 | 2 / 50 | 1 / 51 |
| serious Total, serious adverse events | 0 / 50 | 1 / 48 | 1 / 50 | 0 / 51 |
Outcome results
Primary
Axial Length
Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique.
Time frame: 6-month follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 | Axial Length | 0.119 mm | Standard Deviation 0.1008 |
| Test 2 | Axial Length | 0.135 mm | Standard Deviation 0.1165 |
| Test 3 | Axial Length | 0.079 mm | Standard Deviation 0.1251 |
| Control | Axial Length | 0.189 mm | Standard Deviation 0.1206 |
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [-0.106, -0.02]Mixed Models Analysis
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [-0.1, -0.013]Mixed Models Analysis
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [-0.149, -0.062]Mixed Models Analysis
Primary
Spherical Equivalent of Cycloplegic Autorefraction (SECAR)
SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor.
Time frame: 6-month follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 | Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | -0.26 D | Standard Deviation 0.32 |
| Test 2 | Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | -0.25 D | Standard Deviation 0.35 |
| Test 3 | Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | -0.12 D | Standard Deviation 0.27 |
| Control | Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | -0.35 D | Standard Deviation 0.33 |
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [-0.04, 0.21]Mixed Models Analysis
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [-0.01, 0.25]Mixed Models Analysis
Comparison: It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.95% CI: [0.09, 0.35]Mixed Models Analysis