Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMO-114 | Experimental | Test Lens 1 |
|
| EMO-116 | Experimental | Test Lens 2 |
|
| EMO-118 | Experimental | Test Lens 3 |
|
| EMO-117 | Active Comparator | Test Lens 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMO-114 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length | Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique. | 6-month follow-up |
| Spherical Equivalent of Cycloplegic Autorefraction (SECAR) | SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor. | 6-month follow-up |
Not provided
Not provided
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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.
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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 7 and 12 years of age (inclusive).
Have normal eyes (i.e., no ocular medications or infections of any type).
Distance subjective best-sphere refraction must be between -0.75D and -4.50D (inclusive) in each eye.
Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
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.
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).
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai EENT Hospital | Shanghai | 200031 | China |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test 1 | Subjects randomized to receive senofilcon A (Test 1) lens throughout the entire duration of the study |
| FG001 | Test 2 | Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study |
| FG002 | Test 3 | Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study |
| FG003 | Control | Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test 1 | Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study |
| BG001 | Test 2 | Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Axial Length | Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded. | Posted | Mean | Standard Deviation | mm | 6-month follow-up | eyes | eyes |
|
Throughout the duration of the study, 6-month up to 1 year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test 1 | Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis of Left Elbow and Upper Arm | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xu Cheng - Sr. Principal Clinical Scientist | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | xcheng6@its.jnj.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2018 | May 13, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| EMO-116 | Device | 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. |
|
|
| EMO-118 | Device | 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. |
|
|
| EMO-117 | Device | 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. |
|
|
| Lens Discomfort |
|
| Unsatisfactory Visual Response due to Test Article |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Lens Handling Difficulties |
|
| Subject Decided to Not Wear Contact Lenses |
|
| BG002 | Test 3 | Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study |
| BG003 | Control | Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Count of Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Test 3 | Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study |
| OG003 | Control | Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study |
|
|
|
| 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. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded. | Posted | Mean | Standard Deviation | D | 6-month follow-up | eye | eye |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 9 |
| 50 |
| EG001 | Test 2 | Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study | 0 | 48 | 1 | 48 | 4 | 48 |
| EG002 | Test 3 | Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study | 0 | 50 | 1 | 50 | 2 | 50 |
| EG003 | Control | Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study | 0 | 51 | 0 | 51 | 1 | 51 |
| Pneumonia Mycoplasma Acute Bronchitis , Leukopenia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
| eye |
|
Superiority is established if the adjusted lower confidence limit is above 0. |
| 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. | Mixed Models Analysis | Kenward and Roger method was used for the denominator degrees of freedom | Mean Difference | 0.12 | Standard Error of the Mean | 0.054 | 2-Sided | 95 | -0.01 | 0.25 | Mean difference was calculated as Test - Control | Superiority | Superiority is established if the adjusted lower confidence limit is above 0. |
| 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. | Mixed Models Analysis | Kenward and Roger method was used for the denominator degrees of freedom. | Mean Difference | 0.22 | Standard Error of the Mean | 0.054 | 2-Sided | 95 | 0.09 | 0.35 | Mean difference was calculated as Test - Control | Superiority | Superiority is established if the adjusted lower confidence limit is above 0. |