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This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test1/Test2/Control | Experimental | Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Test2/Control. |
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| Test1/Control/Test2 | Experimental | Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Control/Test2. |
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| Test2/Test1/Control | Experimental | Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Test1/Control. |
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| Test2/Control /Test1 | Experimental | Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Control /Test1. |
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| Control/Test1/Test2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-Day Acuvue Moist | Device | Run-in Contact Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Visual Performance (LogMAR) | Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit. | Up to 2-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy of the form.
Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information).
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 7 and 17 (inclusive) years of age at the time of screening.
By self-report, habitually wear soft contact lenses or be a current non-contact lens wearer interested in soft lens wear.
The non-vertex corrected best sphere distance refraction must be between -1.00 D and -4.50 D (inclusive) in each eye.
The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be less than or equal to 0.75 D (inclusive) in each eye with any degree of axis.
The distance visual acuity with best sphere distance correction must be 20/25 or better in each eye.
Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes.
Have 20/40 or better vision in each eye with wearable spectacles or uncorrected.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Optique | Houston | Texas | 77005 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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A total of 79 subjects were enrolled in this study. Of those enrolled, 75 subjects were randomized and dispensed at least one study lens, while 4 subjects failed to meet all eligibility criteria. Of those dispensed, 65 subjects completed the study while, 10 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in Lens/Test 2/Test 1/Control | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) [Test 2] during Period 2, senofilcon A C3 (EMO-118) [Test 1] during Period 3 and omafilcon A [Control] during Period 4. |
| FG001 | Run-in Lens/Test 2/Control/Test 1 | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) [Test 2] during Period 2, omafilcon A [Control] during Period 3 and senofilcon A C3 (EMO-118) [Test 1] during Period 4. |
| FG002 | Run-in Lens/Test 1/Test 2/Control | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) [Test 1] during Period 2, senofilcon A C3 (EMO-114) [Test 2] during Period 3 and omafilcon A [Control] during Period 4. |
| FG003 | Run-in Lens/Test 1/Control/Test 2 | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) [Test 1] during Period 2, omafilcon A [Control] during Period 3 and senofilcon A C3 (EMO-114) [Test 2] during Period 4. |
| FG004 | Run-in Lens/Control/Test 2/Test 1 | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A [Control] during Period 2, senofilcon A C3 (EMO-114) [Test 2] during Period 3 and senofilcon A C3 (EMO-118) [Test 1] during Period 4. |
| FG005 | Run-in Lens/Control/Test1/Test2 | All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A [Control] during Period 2, senofilcon A C3 (EMO-118) [Test 1] during Period 3 and senofilcon A C3 (EMO-114) [Test 2] during Period 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Period 1 |
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| Period 2 |
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| 3 |
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| 4 |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects dispensed a study lens. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All subjects dispensed a study lens. |
| 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 | Binocular Visual Performance (LogMAR) | Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit. | All subjects who successfully completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | Up to 2-Week Follow-up |
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Throughout the duration of the study. Approximately 2 months per subject.
All subjects dispensed a study lens.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in: Etafilcon A | Subjects that wore the run-in lens, etafilcon A during period 1 of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. (JJVC) | 614-531-6781 | anixon1@its.jnj.com |
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| 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 | Mar 29, 2022 | Mar 20, 2025 | Prot_SAP_000.pdf |
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Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test1/Test2. |
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| Control/Test2/Test1 | Experimental | Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test2/Test1. |
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| EMO-118 | Device | Test Lens1 |
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| EMO-114 | Device | Test Lens2 |
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| MiSight® 1 day | Device | Control Lens |
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| Subject No Longer Meets Eligibility Criteria |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | All subjects dispensed a study lens. | Count of Participants | Participants |
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| Race (NIH/OMB) | All subjects dispensed a study lens. | Count of Participants | Participants |
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| Region of Enrollment | All subjects dispensed a study lens. | Count of Participants | Participants |
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| OG001 | Senofilcon A C3 (EMO-114) [Test 2] | Subjects that wore senofilcon A C3 (EMO-114) [Test 2] during any point of the study. |
| OG002 | Senofilcon A C3 (EMO-118) [Test 1] | Subjects that wore senofilcon A C3 (EMO-118) [Test 1] during any point of the study. |
| OG003 | Omafilcon A (MS1D) [Control] | Subjects that wore omafilcon A [Control] during any point of the study. |
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| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Senofilcon A C3 (EMO-114) | Subjects that wore senofilcon A C3 (EMO-114) during any point of the study. | 0 | 69 | 0 | 69 | 0 | 69 |
| EG002 | Senofilcon A C3 (EMO-118) | Subjects that wore senofilcon A C3 (EMO-118) during any point of the study. | 0 | 70 | 0 | 70 | 0 | 70 |
| EG003 | Omafilcon A | Subjects that wore omafilcon A during any point of the study. | 0 | 69 | 0 | 69 | 0 | 69 |
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