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The study is designed to test five new soft contact lens color pattern variants to determine whether the test lens makes the wearers eyes look bigger, more defined or enhances their overall appearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon test contact lens Variant AP | Experimental |
| |
| etafilcon test contact lens Variant JG | Experimental |
| |
| etafilcon test contact lens Variant CS | Experimental |
| |
| etafilcon test contact lens Variant VC | Experimental |
| |
| etafilcon test contact lens Variant LA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon test contact lens Variant AP | Device | Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject in Agreement (Bigger Eyes) | Subjects' responses to the question "Make my eye look bigger" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion |
| Number of Subject in Agreement (Defines Eyes) | Subjects' responses to the question "Define my eye" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion |
| Number of Subject in Agreement (Enhance Eyes) | Subjects' responses to the question "Enhance my overall appearance" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hung Hom | Kowloon | Hong Kong |
A total of 257 subjects were enrolled into this study. Of the enrolled subjects, 240 subjects were dispensed at least 1 study lenses, while 17 subjects failed to meet the eligibility criteria. No subjects were discontinued during the course of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AP-CS-LA-JG-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG001 | AP-JG-CS-VC-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG002 | AP-LA-VC-CS-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG003 | AP-VC-JG-LA-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG004 | CS-AP-VC-JG-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG005 | CS-JG-AP-LA-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG006 | CS-VC-LA-AP-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG007 | CS-LA-JG-VC-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG008 | JG-AP-LA-VC-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG009 | JG-CS-VC-LA-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG010 | JG-LA-CS-AP-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG011 | JG-VC-AP-CS-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG012 | LA-AP-JG-CS-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG013 | LA-CS-AP-VC-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG014 | LA-JG-VC-AP-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG015 | LA-VC-CS-JG-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG016 | VC-AP-CS-LA-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG017 | VC-CS-JG-AP-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG018 | VC-JG-LA-CS-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| FG019 | VC-LA-AP-JG-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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All subjects that were dispensed at least 1 study lens
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| ID | Title | Description |
|---|---|---|
| BG000 | AP-CS-LA-JG-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG001 | AP-JG-CS-VC-LA |
| 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 | Number of Subject in Agreement (Bigger Eyes) | Subjects' responses to the question "Make my eye look bigger" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints | Posted | Number | Participants | 15-20 Minutes Post Lens Insertion |
|
Throughout the duration of the study. Approximately 2 hours 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 | AP-CS-LA-JG-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charis Lau, Pharm.D., O.D., FAAO | Johnson & Johnson Vision Care Inc. | (904) 443-1293 | MLau87@ITS.JNJ.com |
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|
| etafilcon test contact lens Variant JG | Device | Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens. |
|
| etafilcon test contact lens Variant CS | Device | Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens. |
|
| etafilcon test contact lens Variant VC | Device | Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens. |
|
| etafilcon test contact lens Variant LA | Device | Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens. |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
| BG002 | AP-LA-VC-CS-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG003 | AP-VC-JG-LA-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG004 | CS-AP-VC-JG-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG005 | CS-JG-AP-LA-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG006 | CS-VC-LA-AP-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG007 | CS-LA-JG-VC-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG008 | JG-AP-LA-VC-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG009 | JG-CS-VC-LA-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG010 | JG-LA-CS-AP-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG011 | JG-VC-AP-CS-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG012 | LA-AP-JG-CS-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG013 | LA-CS-AP-VC-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG014 | LA-JG-VC-AP-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG015 | LA-VC-CS-JG-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG016 | VC-AP-CS-LA-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG017 | VC-CS-JG-AP-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG018 | VC-JG-LA-CS-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG019 | VC-LA-AP-JG-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants |
| BG020 | Total | Total of all reporting groups |
| Years |
|
| 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 |
|
Subjects that wore the CS investigational lens during any of the 5 period of the study. |
| OG002 | JG-etafilcon A | Subjects that wore the JG investigational lens during any of the 5 period of the study. |
| OG003 | LA-etafilcon A | Subjects that wore the LA investigational lens during any of the 5 period of the study. |
| OG004 | VC- Etafilcon A | Subjects that wore the VC investigational lens during any of the 5 period of the study. |
|
|
| Primary | Number of Subject in Agreement (Defines Eyes) | Subjects' responses to the question "Define my eye" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints | Posted | Number | Participants | 15-20 Minutes Post Lens Insertion |
|
|
|
| Primary | Number of Subject in Agreement (Enhance Eyes) | Subjects' responses to the question "Enhance my overall appearance" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens. | Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints | Posted | Number | Participants | 15-20 Minutes Post Lens Insertion |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | AP-JG-CS-VC-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG002 | AP-LA-VC-CS-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG003 | AP-VC-JG-LA-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG004 | CS-AP-VC-JG-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG005 | CS-JG-AP-LA-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG006 | CS-VC-LA-AP-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG007 | CS-LA-JG-VC-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG008 | JG-AP-LA-VC-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG009 | JG-CS-VC-LA-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG010 | JG-LA-CS-AP-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG011 | JG-VC-AP-CS-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG012 | LA-AP-JG-CS-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG013 | LA-CS-AP-VC-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG014 | LA-JG-VC-AP-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG015 | LA-VC-CS-JG-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG016 | VC-AP-CS-LA-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG017 | VC-CS-JG-AP-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG018 | VC-JG-LA-CS-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
| EG019 | VC-LA-AP-JG-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 0 | 12 | 0 | 12 |
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