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This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence ×2-period crossover study to evaluate ocular physiology following contact lens wear.
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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 (TEST/CONTROL) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. |
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| CONTROL/TEST | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (CONTROL/TEST) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECISION1® for Astigmatism Contact Lenses | Device | TEST |
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| 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 |
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Inclusion Criteria:
Potential subjects must satisfy of all 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. Inclusion Criteria at Baseline Evaluation
The subject must:
Have the spherical component of their vertex-corrected distance refraction must be between -0.875 to -4.625 DS (inclusive) in each eye.
Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.625 DC and 1.625 DC in both eyes.
Have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive) in each eye.
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 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 | ||
| Sabal Eye Care |
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 78 subjects were enrolled in this study. Of those enrolled, 73 subjects were dispensed at least one study lens, while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 69 subjects completed the study while 4 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Verofilcon A/Stenfilcon A | Subjects randomized to receive the verofilcon A lens during period 1 and the stenfilcon A lens during period 2. |
| FG001 | Stenfilcon A/Verofilcon A | Subjects randomized to receive the stenfilcon A lens during period 1 and the verofilcon A lens during period 2. |
| 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 | Dec 15, 2021 |
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| MyDay® Toric Soft Contact Lenses |
| Device |
CONTROL |
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| Longwood |
| Florida |
| 32779 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Professional Vision Care Inc. - Westerville | Westerville | Ohio | 43081 | United States |
| Botetourt Eyecare LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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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 |
|---|---|
| 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 | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | Up to 1-Week Follow-up | Eyes | Eyes |
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Throughout the duration of the study; approximately 21 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 | Verofilcon A | Subjects that wore the verofilcon A lens during either the first or second period of the study. | 0 | 72 | 0 | 72 | 0 | 72 |
| EG001 | Stenfilcon A | Subjects that wore the stenfilcon A lens during either the first or second period of the study. | 0 | 72 | 0 | 72 | 0 | 72 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | bstraker@its.jnj.com |
| May 9, 2023 |
| Prot_SAP_000.pdf |
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| Other |
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