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This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AO1DfA/DT1fA | Experimental | Eligible subjects will be randomized into the AO1DfA/DT1fA wear sequence, to wear the test lens followed by the control lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. |
|
| DT1Fa/AO1DfA | Experimental | Eligible subjects will be randomized into the DT1Fa/AO1DfA wear sequence, to wear the control lens followed by the test lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) | Device | Test Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Monocular Visual Acuity (LogMAR) | Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart. | Approximately 15-minutes Post Lens Insertion |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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 |
|---|---|---|---|---|---|---|
| The University of Manchester, Department of Optometry & Neuroscience | Manchester | M139PL | United Kingdom |
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 6 subjects were enrolled at a single clinical site. Of those enrolled, 1 subject failed to meet all eligibility criteria and 5 subjects were dispensed both study lenses and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A/Senofilcon A | Subjects that wore the delefilcon A lens in the first period and senofilcon A in the second period. |
| FG001 | Senofilcon A/Delefilcon A | Subjects that wore the senofilcon A lens in the first period and the delefilcon A lens in the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed a 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 | Distance Monocular Visual Acuity (LogMAR) | Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart. | All subjects fitted both study lenses and completed the study | Posted | Mean | Standard Deviation | logMAR | Approximately 15-minutes Post Lens Insertion | Eyes | Eyes |
|
Throughout the duration of the study; approximately 1-10 days per subject.
All subjects fitted at least 1 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 | Senofilcon A | Subjects that wore the senofilcon A lens in either the first or second period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson & Johnson Vision Care Study Contact | Johnson & Johnson Vision Care | 1-800-843-2020 | RFrankl1@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 | Oct 3, 2024 | Jan 23, 2026 | Prot_SAP_001.pdf |
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| Dailies Total 1 for Astigmatism (DT1fA) |
| Device |
Control Lens |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects that wore the delefilcon A lens in either the first or second period.
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Delefilcon A | Subjects that wore the delefilcon A lens in either the first or second period. | 0 | 5 | 0 | 5 | 0 | 5 |
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