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This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A Toric Multifocal | Experimental |
| |
| etafilcon A Multifocal | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Fitting Guides | Device | Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit. |
| Measure | Description | Time Frame |
|---|---|---|
| The Average Number of Fitting Modifications to Optimize Vision | The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported. | 15 minutes post lens insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Responses to Individual Item 1 | Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vistakon Research Clinic | Jacksonville | Florida | 32256 | United States |
This was a non-randomized study. The JJVC fitting guide, subjects responses and eye care practitioner opinions dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors.
A total of 23 subjects were enrolled into this study. Of the enrolled subjects all 23 were dispensed a study lens. Of the dispensed subjects 22 completed the study while 1 subjects was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal | Subjects that wore the etafilcon A multifocal lens in both eyes for the entire duration of the study. |
| FG001 | Toric Multifocal | Subjects that wore the etafilcon A Toric multifocal lens in both eyes for the entire duration of the study. |
| FG002 | Toric Multifocal/Multifocal | Subjects that wore the etafilcon A toric multifocal lens in their right eye and the etafilcon A multifocal lens in their left eye for the entire duration of the study. |
| FG003 | Multifocal/Toric Multifocal | Subjects that wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye for the entire duration of the study. |
| FG004 | Multifocal/Toric Multifocal -Toric Multifocal | Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye and then wore the etafilcon A toric multifocal lens in both eyes for the remainder of the study. |
| FG005 | Multifocal/Toric Multifocal - Multifocal -Toric Multifocal | Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye. Then wore the etafilcon A multifocal lens in both eyes secondary and lastly wore then etafilcon A toric multifocal lens in both eyes for the remainder of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All subjects that completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed at least 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 | The Average Number of Fitting Modifications to Optimize Vision | The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Lens | 15 minutes post lens insertion | Eyes | Eyes |
|
Throughout the entire duration of the study. Approximately 1 day 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 | Multifocal | Subjects that wore the etafilcon A multifocal lens in either or both eyes at least once during the course of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen - SR PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision | 904 443-3402 | TKarkkai@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 | Mar 14, 2017 | Mar 30, 2018 | Prot_SAP_000.pdf |
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While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
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|
| 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 2 | Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 3 | Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 4 | Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 5 | Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 6 | Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 7 | Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 8 | Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 9 | Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Subject's Responses to Individual Item 10 | Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported. | 15 Minuted Post Lens Insertion |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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|
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| Secondary | Subject's Responses to Individual Item 1 | Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 2 | Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 3 | Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 4 | Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 5 | Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 6 | Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 7 | Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 8 | Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 9 | Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 10 | Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported. | All subjects that completed the study without a major protocol deviation. | Posted | Number | percentage of participants | 15 Minuted Post Lens Insertion |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Toric Multifocal | Subjects that wore the etafilcon A Toric multifocal lens in either or both eyes at least once during the course of the study. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Measurements |
|---|---|
|
| Slightly Satisfied |
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| Not at all Satisfied |
|
| Title | Measurements |
|---|---|
|
| Slightly likely |
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| Not at all likely |
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| Title | Measurements |
|---|---|
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| Dissatisfied |
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| Very Dissatisfied |
|
| Title | Measurements |
|---|---|
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| In a Newspaper |
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| On a search engine (ex: Google) |
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| On a Blog |
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| On Social Media Networks |
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| On YouTube |
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| In an Online Forum |
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| On your Vision Care Insurance Website |
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| Talking with friends family or colleagues |
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| Talking with an eye doctor |
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| Online, but not through an advertisement |
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| Other |
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| Title | Measurements |
|---|---|
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| Sometimes |
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| Rarely |
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| Never |
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| Title | Measurements |
|---|---|
|
| Readers |
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| Progressive lenses |
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| Other |
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| Title | Measurements |
|---|---|
|
| Somewhat Worse |
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| Much Worse |
|
| Title | Measurements |
|---|---|
|
| Unexcited |
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| Very Unexcited |
|
| Title | Measurements |
|---|
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| Fair |
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| Poor |
|
| Title | Measurements |
|---|
|
| Fair |
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| Poor |
|