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3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participating Subjects | Experimental | Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Investigational Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 12-16 Day Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EYE Center Optometric | Rocklin | California | 95677 | United States | ||
| Dr. Ted Brink & Associates |
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A total of 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A With PVP | All subject wore the etafilcon A with PVP lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A With PVP | All subject wore the etafilcon A with PVP lens throughout the entire duration of the study. |
| 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 | Overall Vision | Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Subjects that completed all visits without a major protocol deviation documented as impacted the assessment of the primary endpoint. | Posted | Mean | Standard Deviation | Units on a Scale | 12-16 Day Follow-up |
|
Throughout the entire duration of the study. Approximately 2-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 | Etafilcon A With PVP | All subjects wore the etafilcon A lens with PVP throughout the entire duration 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 1, 2017 | Dec 6, 2019 | Prot_SAP_000.pdf |
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| Jacksonville |
| Florida |
| 32225 |
| United States |
| Vistakon Research Clinic | Jacksonville | Florida | 32256 | United States |
| Golden Vision | Sarasota | Florida | 34232 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| University of Indiana School of Optometry | Bloomington | Indiana | 47405 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| 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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| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
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