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This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Test/Control). |
|
| Control/Test | Experimental | Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Control/Test). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A investigational cosmetic lens 1 | Device | TEST |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported. | 5- Minutes Post-Lens Fitting |
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Inclusion Criteria:
-Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stam & Associates Eye Care | Jacksonville | Florida | 32256 | United States | ||
| Frazier Vision, Inc |
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 58 subjects were enrolled into this study. Of those enrolled, 56 were dispensed at least 1 study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 55 subjects completed the study while 1 subject was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1. |
| FG001 | Control/Test | Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects who were dispensed a study lens. |
| 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 Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Number | proportion of eyes | 5- Minutes Post-Lens Fitting | Eyes | Eyes |
|
Throughout the duration of the study. Approximately 3 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 (Etafilcon A With Cosmetic Pattern) | Subjects that wore the Test lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop, OD, MS, FAAO-Sr. Principal Research Optometrist | Johnson & Johnson Vision Care | 904-443-1783 | mbishop4@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 | Jul 28, 2020 | Sep 15, 2021 | Prot_SAP_000.pdf |
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| etafilcon A investigational cosmetic lens 2 |
| Device |
CONTROL |
|
| Tyler |
| Texas |
| 75703 |
| United States |
| Vital Eyecare Center | Mong Kok | Kowloon | Hong Kong |
| Sight Enhancement Center | Yau Ma Tei | Kowloon | Hong Kong |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Subjects that wore the Test lens in either the first or second period of the study. |
| OG001 | Control (Etafilcon A With Cosmetic Pattern) | Subjects that wore the Control lens in either the first or second period of the study. |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Control (Etafilcon A With Cosmetic Pattern) | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 56 | 0 | 56 | 0 | 56 |
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