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This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative | Active Comparator | Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period. |
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| Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal | Active Comparator | Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifocal Contact Lens 1 | Device | Dailies Total 1 Multifocal Contact Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Binocular Visual Acuity | Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. | 1-Week Follow-up |
| Near Binocular Visual Acuity | Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Quality of Vision | Overall quality of 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. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between at least 40 years of age and not greater than 70 years of age.
The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
The subject's refractive cylinder must be ≤ -0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
The subject must own a pair of wearable spectacles if required for their distance vision.
The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Vision | Sarasota | Florida | 34232 | United States | ||
| ABQ Eye Care |
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A total of 78 subjects were enrolled into this study. Of the enrolled all 78 were dispensed at least one study lens. Of the dispensed subjects 71 completed the study, while 7 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A/Nesofilcon A | All subjects that were randomized to receive the delefilcon A lens during the first period of the study and the nesofilcon A lens during the second period of the study. |
| FG001 | Nesofilcon A/Delefilcon A | All subjects that were randomized to receive the nesofilcon A during the first period of the study and the delefilcon A lens during the second period of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects that were dispensed a 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 | Distance Binocular Visual Acuity | Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up | Eyes | Eyes |
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Throughout the entire duration of the study. Approximately 1 month 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 | Delefilcon A | All subjects that wore the delefilcon A lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen, OD, MS, FAAO- Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 1-904-443-3402 | 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 | Sep 1, 2017 | Oct 31, 2018 | Prot_SAP_000.pdf |
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| Multifocal Contact Lens 2 | Device | Biotrue ONEday for Presbyopia Contact Lenses |
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| Spherical Contact Lens 2 | Device | BioTrue ONEDay Spherical |
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| 1-Week Follow-up |
| Albuquerque |
| New Mexico |
| 87109 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| Incorrect Lens Dispensed |
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| Unsatisfactory Lens Fitting |
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| NOT COMPLETED |
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| 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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| Primary | Near Binocular Visual Acuity | Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up | Eyes | Eyes |
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| Secondary | Overall Quality of Vision | Overall quality of 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 study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Nesofilcon A | All subjects that wore the nesofilcon A lens during either the first or second period of the study. | 0 | 78 | 0 | 78 | 0 | 78 |
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| Linear mixed model analysis |
Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. |
| LS Mean Estimate |
| 0.141 |
| Standard Error of the Mean |
| 0.0147 |
| 2-Sided |
| 95 |
| 0.112 |
| 0.170 |
| Superiority |
Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near. |
| Linear Mixed Model Analysis |
Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. |
| LS Mean Estimate |
| 46.4 |
| Standard Error of the Mean |
| 2.21 |
| 2-Sided |
| 95 |
| 42.1 |
| 50.8 |
| Superiority |
Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points. |