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This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control. |
|
| Control/Test | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue® Oasys MAX 1-Day | Device | TEST Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Acceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported. | 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.
Between 18 and 40 (inclusive) years of age at the time of screening.
They agree not to participate in other clinical research while enrolled on this study.
They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.
They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).
They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
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 | Manchester | M13 9PL | 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 16 subjects were enrolled in this study. Of those enrolled, 14 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All dispensed subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A / Senofilcon A | Subjects randomized to receive the delefilcon A lens during period 1 and the senofilcon A lens during period 2. |
| FG001 | Senofilcon A / Delefilcon A | Subjects randomized to receive the senofilcon A lens during period 1 and the delefilcon A lens during period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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 |
|
| 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 | Proportion of Eyes With Acceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported. | 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 |
|
Throughout the duration of the study. Approximately 28 days 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 | Delefilcon A | Subjects that wore the delefilcon A lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, O.D., M.S. | Johnson & Johnson Vision Care (JJVC) | 1-800-843-2020 | jbuch@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 | Aug 19, 2022 | Nov 30, 2023 | Prot_SAP_000.pdf |
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| Dailies Total 1 |
| Device |
CONTROL Lens |
|
| NOT COMPLETED |
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| Years |
|
| 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 |
|
Subjects that wore the senofilcon A lens in either the first or second period of the study. |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Senofilcon A | Subjects that wore the senofilcon A lens in either the first or second period of the study. | 0 | 14 | 0 | 14 | 0 | 14 |
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