Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence × 2-period crossover study to evaluate ocular physiology following approximately one week of contact lens wear.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods. |
|
| CONTROL/TEST | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST LENS | Device | AO1DfA manufactured with PG hydration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. | Up to 1-Week Follow-up |
Not provided
Not provided
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.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear 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 2 days per week during the past month.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have astigmatic 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:
The submit must not:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| Maitland Vision Center - North Orlando Ave |
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
Not provided
Not provided
Not provided
A total of 66 subjects were enrolled in this study. Of those enrolled, 65 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 62 subjects completed the study while 3 subjects were discontinued.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Manufactured With PG Hydration\Senofilcon A Manufactured With IPA Hydration | Subjects randomized to receive the senofilcon A contact lenses manufactured with PG hydration during the first period and senofilcon A manufactured with IPA hydration during the second period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
| 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 | Jun 27, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CONTROL LENS |
| Device |
AO1DfA manufactured with IPA hydration |
|
| Maitland |
| Florida |
| 32751 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| Senofilcon A Manufactured With IPA Hydration\Senofilcon A Manufactured With PG Hydration |
Subjects randomized to receive the senofilcon A contact lenses manufactured with IPA hydration during the first period and senofilcon A manufactured with PG hydration during the second period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
All subjects dispensed a study lens.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total | Total Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. | All subjects that were dispensed at least one study lens. | Posted | Number | proportion of eyes | Up to 1-Week Follow-up | eyes | eyes |
|
|
|
Throughout the duration of the study; approximately 3-weeks per subject.
Not provided
Not provided
| 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 Manufactured With PG Hydration | Subjects that wore the senofilcon A contact lenses manufactured with PG hydration during either the first or second period of the study. | 0 | 64 | 0 | 64 | 0 | 64 |
| EG001 | Senofilcon A Manufactured With IPA Hydration | Subjects that wore the senofilcon A contact lenses manufactured with IPA hydration during either the first or second period of the study. | 0 | 63 | 0 | 63 | 0 | 63 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Straker | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | bstraker@its.jnj.com |
| Aug 25, 2023 |
| Prot_SAP_000.pdf |
Not provided