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This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.
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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 (5 to 7 days) with a wash-out period (2 to 5 days) between wears. |
|
| CONTROL/TEST | Experimental | Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST LENS | Device | etafilcon A with cosmetic pattern |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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:
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 |
|---|---|---|---|---|---|---|
| Vital Eyecare Center Limited | Mong Kok | Kowloon | Hong Kong | |||
| Sight Enhancement Center |
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 89 subjects were enrolled in this study. Of those enrolled, 77 subjects were dispensed at least one study lens. Of those dispensed, 54 subjects completed the study while 23 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test [Etafilcon A] \ Control [Etafilcon A] | Subjects in this sequence were randomized to receive the Test [etafilcon A] lens during the first period and the Control [etafilcon A] lens during the second period. |
| FG001 | Control [Etafilcon A] \ Test [Etafilcon A] | Subjects in this sequence were randomized to receive the Control [etafilcon A] lens during the first period and the Test [etafilcon A] lens during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed one 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 LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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 subject dispensed at least one study lens. | 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] | Subjects that wore the Test [etafilcon A] lens during any point in the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | bpall@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 | Nov 10, 2023 | Prot_SAP_000.pdf |
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Brand masking: subjects, investigators, and clinical site personnel will be unaware of the identity (brand) of both study lenses.
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| CONTROL LENS |
| Device |
Acuvue 1-Day Define Fresh Honey |
|
| Yau Ma Tei |
| Kowloon |
| Hong Kong |
| Subject No Longer Meets Eligibility Criteria |
|
| Covid-19 Related |
|
| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects that wore the Test [etafilcon A] lens during any of the two study periods.
| OG001 | Control [Etafilcon A] | Subjects that wore the Control [etafilcon A] lens during any of the two study periods. |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Control [Etafilcon A] | Subjects that wore the Control [etafilcon A] lens during any point in the study. | 0 | 71 | 0 | 71 | 0 | 71 |
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