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This will be a multi-site, bilateral, dispensing, randomized, controlled, double-masked, 2×2 crossover study to evaluate ocular physiological response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control). Each wear period will be approximately 2 weeks in duration, with a washout period of approximately 1 week between wear periods. Subjects will be advised to wear the study lenses for a minimum of 8 hours per day on at least 5 days per week of each wear period. |
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| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test). Each wear period will be approximately 2 weeks in duration, with a washout period of approximately 1 week between wear periods. Subjects will be advised to wear the study lenses for a minimum of 8 hours per day on at least 5 days per week of each wear period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senofilcon A contact lenses (TEST) | Device | Rotationally stabilized astigmatic soft contact lenses in senofilcon A containing a chromophore to filter High-Energy Visible Light (HEVL) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up, 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens. | 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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during the past four weeks.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
Have best corrected monocular distance visual acuity of 20/30 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 |
|---|---|---|---|---|---|---|
| Omega Vision Center | Longwood | Florida | 32779 | United States | ||
| Maitland Vision Center - North Orlando Ave |
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 67 subjects were enrolled in this study. Of those enrolled, all 67 subjects were dispensed at least one study lens. Of those dispensed, 66 subjects completed the study while one subject was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A/ Senofilcon A (C3) | Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A (C3) lens during the second period |
| FG001 | Senofilcon A (C3)\Delefilcon A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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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 | Nov 27, 2023 |
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| Delefilcon A contact lenses (CONTROL) | Device | DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA) |
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| Maitland |
| Florida |
| 32751 |
| United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Professional Vision Care Inc. - Westerville | Westerville | Ohio | 43081 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
Subjects in this sequence were randomized to receive the senofilcon A (C3) lens during the first period and the delefilcon A lens during the second period
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| NOT COMPLETED |
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| Period 2 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | Subjects dispensed at least one 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 | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up, 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of Eyes | Up to 2-Week Follow-up | Eyes | Eyes |
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Throughout the entire duration of the study. Approximately five weeks per subject.
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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 | Senofilcon A (C3) | Subjects that wore the senofilcon A (C3) lens during any of the two study periods. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG001 | Delefilcon A | Subjects that wore the delefilcon A lens during any of the two study periods. | 0 | 67 | 0 | 67 | 0 | 67 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Murakami, OD, MPH, FAAO | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | dmuraka2@its.jnj.com |
| Feb 5, 2025 |
| Prot_SAP_000.pdf |
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| Multiple |
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