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This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test/control/control | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
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| control/test/test | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore | Device | TEST Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| CLUE Comfort Score | Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type. | 1-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy of all the following criteria to be enrolled in the study.
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 years of age (inclusive) at the time of screening.
By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours 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:
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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 |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates, PA - City Square Blvd | Jacksonville | Florida | 32218 | United States | ||
| Stam & Associates Eye Care |
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 126 subjects were enrolled in this study. Of those enrolled, all 126 subjects were dispensed at least one study lens. Of those dispensed, 119 subjects completed the study while 7 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test\Control\Control | Subjects in this sequence were randomized to receive the Test [senofilcon A (C3) HEV chromophore] lens during the first period and the Control [senofilcon A (C3)] lens during the second and third periods . |
| FG001 | Control\Test\Test |
| 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 | Mar 14, 2022 |
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| ACUVUE OASYS 1-Day for Astigmatism | Device | CONTROL Lens |
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| Jacksonville |
| Florida |
| 32256 |
| United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Southwest Orlando Eye Care | Orlando | Florida | 32819 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Dr. David W. Ferris & Associates | Warwick | Rhode Island | 02888 | 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 Control [senofilcon A (C3)] lens during the first period and the Test [senofilcon A (C3) HEV chromophore] lens during the second and third periods. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All 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 | Number | Participants |
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| Region of Enrollment | 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 | CLUE Comfort Score | Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type. | All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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Throughout the duration of the study; Approximately 3-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 | Test [Senofilcon A (C3) HEV Chromophore] | Subjects that wore the Test [senofilcon A (C3) HEV chromophore] lens during any point in the study. | 0 | 125 | 0 | 125 | 0 | 125 |
| EG001 | Control [Senofilcon A (C3)] | Subjects that wore the Control [senofilcon A (C3)] lens during any point in the study. | 0 | 125 | 0 | 125 | 0 | 125 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | bstraker@its.jnj.com |
| Aug 4, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Subject out of visit window |
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| White |
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| Other |
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