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This study is a single arm, 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 |
|---|---|---|---|
| Toric Multifocal Contact Lens | Experimental | JJVC Investigational Toric Multifocal Contact Lens for Presbyopia |
|
| Multifocal Contact Lens | Experimental | 1-Day Acuvue® Moist Brand Multifocal Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Fitting Guides | Device | Subjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational 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 during a 1 day visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fitting Modifications to Optimize Vision | The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded. | 15 Minutes Post Lens Fitting |
| 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 car practitioner options dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors. The first lens pair (Right/Left) on eye was the same lens pair (Right/Left) the subject ended with.
A total of 23 subjects were enrolled into this study. Of the enrolled subjects 21 were dispensed a study lens and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects all 21 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric Multifocal/Toric Multifocal | Subjects that wore the Toric Multifocal contact lens in both eyes (Right/Left) for the entire duration of the study. |
| FG001 | Toric Multifocal/ Multifocal | Subjects that wore the Toric Multifocal contact lens in their right eye and the Sphere Multifocal contact lens in their left eye for the entire duration of the study. |
| FG002 | Multifocal/Toric Multifocal | Subjects that wore the Sphere Multifocal contact lens in their right eye and the Toric Multifocal contact lens in their left eye for the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed at least one study lens. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Fitting Modifications to Optimize Vision | The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | Lens | 15 Minutes Post Lens Fitting | 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 | Toric Multifocal | Subjects that wore the Toric Multifocal contact lens at any point during this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen, OD MS, FAAO - Sr. Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. | 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 | Apr 17, 2017 | May 1, 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 Minutes 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 Minutes 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 Minutes 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 Minutes 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 Minutes 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 Minutes Post Lens Insertion |
| Subject's Responses to Individual Item 7 | Subjects responses to individual item "How did the new lens you tried as a part of this clinical 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 Minutes 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 Minutes 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 Minutes 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 Minutes Post Lens Insertion |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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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 Minutes Post Lens Insertion |
|
|
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| 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 Minutes Post Lens Insertion |
|
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| 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 Minutes Post Lens Insertion |
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| 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 Minutes Post Lens Insertion |
|
|
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| 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 Minutes 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 Minutes Post Lens Insertion |
|
|
|
| Secondary | Subject's Responses to Individual Item 7 | Subjects responses to individual item "How did the new lens you tried as a part of this clinical 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 Minutes 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 Minutes Post Lens Insertion |
|
|
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| 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 Minutes 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 Minutes Post Lens Insertion |
|
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Multifocal | Subjects that wore the Sphere Multifocal contact lens at any point during this study. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Measurements |
|---|---|
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| Slightly satisfied |
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| Not at all satisfied |
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| Title | Measurements |
|---|---|
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| 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 |
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| 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 |
|---|---|
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| Readers |
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| Progressive Lenses |
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| Other |
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| Title | Measurements |
|---|---|
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| Somewhat worse |
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| Much worse |
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| Title | Measurements |
|---|---|
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| 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 |
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