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This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects will be randomized into one of two possible lens wear sequences, Test/Control. |
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| Control/Test | Experimental | Eligible subjects will be randomized into one of two possible lens wear sequences, Control/Test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRP-200 | Device | JJVC Investigational Contact Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Quality of Vision Score | Overall quality of vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. | 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Scores | Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all of 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 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel 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 5 days per week during the past 30 days.
Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
The subject's refractive cylinder must be 1.00 D or less.
The subject must have best corrected visual acuity of 20/25 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 | Jacksonville | Florida | 32205 | United States | ||
| Flora Chen Poveda, OD, PA |
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 228 subjects were enrolled in this study. Of those enrolled, 227 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 219 subjects completed the study while 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Senofilcon A C3) /Test (Senofilcon A C3) | Subjects randomized to this sequence received the Control lens during the first period and Test lens during the second period. |
| FG001 | Test (Senofilcon A C3) /Control (Senofilcon A C3) |
| 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 18, 2021 |
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| JJVC Marketed Contact Lens | Device | ACUVUE Oasys 1-Day |
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| 2-Week Follow-up |
| Overall Handling Scores | Overall handling scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score for each lens type was reported. | 2-Week Follow-up |
| Orange Park |
| Florida |
| 32073 |
| United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| Visual Eyes | Roswell | Georgia | 30075 | United States |
| Birmingham Vision Care | Bloomfield Township | Michigan | 48301 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Dr. Debbie H. Kim, OD | Closter | New Jersey | 07624 | United States |
| Professional Vision Care, Inc. | Westerville | Ohio | 43081 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Gulf Coast Vision Center, Inc. | Houston | Texas | 77054 | United States |
| Frazier Vision, Inc. | Tyler | Texas | 75703 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
Subjects randomized to this sequence received the Test lens during the first period and Control lens during the second period. |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed a study lens. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| 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 | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Quality of Vision Score | Overall quality of vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Unit on a scale | 2-Week Follow-up |
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| Secondary | Overall Comfort Scores | Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Unit on a scale | 2-Week Follow-up |
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| Secondary | Overall Handling Scores | Overall handling scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score for each lens type was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Unit on a scale | 2-Week Follow-up |
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Throughout the duration of the study; The study duration for each subject was approximately 26 to 30 days.
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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 | Control (Senofilcon A C3) | Subjects that wore the Control lens in either of the two study periods. | 0 | 227 | 0 | 227 | 0 | 227 |
| EG001 | Test (Senofilcon A C3) | Subjects that wore the Test lens in either of the two study periods. | 0 | 227 | 0 | 227 | 0 | 227 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, O.D., M.S., F.A.A.O. | Johnson & Johnson Vision Care, Inc. | 904-608-7238 | jbuch@its.jnj.com |
| Aug 8, 2022 |
| Prot_SAP_000.pdf |
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