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This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens | Experimental | Eligible subjects will be fitted bilaterally with the TEST lens for approximately 2 weeks of wear (two 1-week wear periods). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) | Device | Test Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses | Slit Lamp Findings (SLFs) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported. | 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:
The subject must:
Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form (For subjects aged 18 and older)
Read (or be read to) and sign the Children's Assent (Information and Assent Form) and receive a fully executed copy of the form. (For subjects aged 13 to 17)
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). (For subjects aged 13 to 17)
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 13 and 39 (inclusive) years of age at the time of screening.
By self-report, having never worn any type of contact lenses and never attempted to insert contact lenses.
Have a pair of prescription glasses on hand that corrects distance vision, if determined to be required by the investigator.
The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be ≤ 0.75 DC in each eye.
Subject must have a vertex corrected distance sphero-cylindrical refraction in the range such that appropriate spherical lens powers are available for correction in both eyes. The spherical lens powers available in this study are:
a. -1.00 to -6.00 (in 0.25D steps)
Best corrected monocular distance visual acuity must be 20/20-3 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Poway Eyecare & Optometry | San Diego | California | 92131 | United States | ||
| Omega Vision Center |
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 36 subjects were enrolled in this study. Of those enrolled, 34 subjects were dispensed the study lens, while 1 subject withdrew consent before lens dispensing and 1 subject failed to meet all eligibility criteria. Of those dispensed, 33 subjects completed the study while 1 subject was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Senofilcon A C3) | All eligible subjects were dispensed the study lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test (Senofilcon A C3) | All eligible subjects were dispensed the study lens. |
| 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 | Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses | Slit Lamp Findings (SLFs) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Percentage | Up to 2-Week Follow-up | Eyes | Eyes |
|
Throughout the duration of the study; approximately 2-weeks per subject.
All subjects dispensed the 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 | Test (Senofilcon A C3) | All subjects dispensed the study lens. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson & Johnson Vision Care Study Contact | Johnson & Johnson Vision Care | 1-800-843-2020 | osova@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 12, 2024 | May 14, 2025 | Prot_SAP_000.pdf |
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| Longwood |
| Florida |
| 32779 |
| United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Procare Vision Centers | Granville | Ohio | 43023 | United States |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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