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The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study to confirm a finalized design of a prototype contact lens. There will be eight study lens types, however, each subject will only be randomized to receive two study lens types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myopes - Against the Rule Sequence 1 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Myopes - Against the Rule Sequence 2 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Myopes - With the Rule Sequence 1 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Myopes - With the Rule Sequence 2 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Hyperopes - Against the Rule Sequence 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens | Device | Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Absolute Rotation ≤ 10 Degrees | Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. | 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 |
|---|---|---|---|---|---|---|
| Stam & Associates Eye Care | 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 102 subjects were enrolled in this study. Of those enrolled, all subjects were dispensed both lenses and completed the study. No subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC) | Subjects randomized to this sequence received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) during the first period and then received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) during the second period |
| FG001 | Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC) | Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) during the first period and then received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) during the second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
|
All subjects dispensed at least one study lens.
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| 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 |
| 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 Absolute Rotation ≤ 10 Degrees | Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion | 15-minutes post lens insertion | Eyes | Eyes |
|
Throughout the duration of the study. Approximately 1-Day per Subject.
All subjects dispensed 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 (C3) Multifocal Toric Lens With UV/HEV Filter (Low C) | Subjects that wore the Test lens Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) in either the first or second period of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin | Johnson & Johnson Vision Care (JJVC) | 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 | Jun 2, 2022 | Jun 29, 2023 | Prot_SAP_000.pdf |
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| Experimental |
Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Hyperopes - Against the Rule Sequence 2 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at time bilaterally over 2 wear periods. |
|
| Hyperope - With the Rule Sequence 1 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Hyperope - With the Rule Sequence 2 | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. |
|
| Longwood |
| Florida |
| 32779 |
| United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Center for Ophthalmic and Vision Research/Eye Associates of New York | Manhattan | New York | 10022 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC) | Subjects that wore the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) in either the first or second period of the study. |
|
|
|
| 0 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC) | Subjects that wore the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) in either the first or second period of the study. | 0 | 102 | 0 | 102 | 0 | 102 |
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