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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 will be randomized to the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (1 week) with a wash-out period (1 week) between wear periods. |
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| CONTROL/TEST | Experimental | Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (1 week) with a wash-out period (1 week) between wear periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST LENS | Device | DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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), however data collected at the 1-week follow-up is the primary endpoint. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The percentage of eyes with SLF with grade 3 or higher was reported for each lens type. | 1-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all the following criteria to be enrolled in the study.
The subject must:
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 |
|---|---|---|---|---|---|---|
| Sabal Eye Care | Longwood | Florida | 32779 | 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
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A total of 66 subjects were enrolled in this study. Of those enrolled, all 66 subjects were dispensed at least one study lens. Of those dispensed, 65 subjects completed the study while 1 subject was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (DT1fA) \ Control (P1fA) | Subjects randomized to this sequence received the Test (DT1fA) lens during the first period and then received the Control (P1fA) lens during the second period |
| FG001 | Control (P1fA) \ Test (DT1fA) |
| 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 | Jul 22, 2022 |
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| CONTROL LENS | Device | PRECISION1â„¢ for Astigmatism Contact Lenses (P1fA) |
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| Maitland |
| Florida |
| 32751 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Professional Vision Care Inc. - Westerville | Westerville | Ohio | 43081 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
Subjects randomized to this sequence received the Control (P1fA) lens during the first period and then received the Test (DT1fA) lens during the second period
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| Period 2 |
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All subjects dispensed one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed at least one 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 | Number | 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 | Percentage 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), however data collected at the 1-week follow-up is the primary endpoint. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The percentage of eyes with SLF with grade 3 or higher was reported for each lens type. | All subjects who were administered at least one study lens and had at least one observation recorded. | Posted | Number | Percent | 1-Week Follow-up | Eyes | Eyes |
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Throughout the duration of the study; approximately 8 weeks 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 (DT1fA) | Subjects that wore the Test lens in either the first or second period of the study. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG001 | Control (P1fA) | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 65 | 0 | 65 | 0 | 65 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker | Johnson & Johnson Vision Care, Inc. (JJVC) 7500 Centurion | 1-800-843-2020 | bstraker@its.jnj.com |
| Sep 26, 2023 |
| Prot_SAP_000.pdf |
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