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This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.
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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) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office. |
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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) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock | Device | CONTROL |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens. | Up to 1-Hour Follow-Up |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| VRC | Jacksonville | Florida | 32256 | 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 31 subjects were enrolled in this study. Of those enrolled, 30 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, all 30 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to receive the Test lens during the first period and the Control lens during the second period. |
| FG001 | Control/Test | Subjects randomized to receive the Control lens during the first period and the Test lens during the second period. |
| 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 | Jan 18, 2023 |
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| Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock | Device | TEST |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | 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 | 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 | ||||||||||||||||||||||||||||||||
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| Primary | Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens. | All subjects that were dispensed at least one study lens. | Posted | Number | Proportion of eyes | Up to 1-Hour Follow-Up | Eyes | Eyes |
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Throughout the duration of the study; approximately 1-day 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 | Subjects that wore the Test lens during either the first or second period of the study. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Control | Subjects that wore the Control lens during either the first or second period of the study. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | bstraker@its.jnj.com |
| Feb 6, 2024 |
| Prot_SAP_000.pdf |
| Native Hawaiian or Other Pacific Islander |
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| White |
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