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This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. |
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| Control/Test | Experimental | Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dailies Total 1® Multifocal Contact Lenses | Device | TEST |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Lens Centration | Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported. | 6 to 8 days |
| Percentage of Participants With Lens Movement | Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported. | 6 to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Handling Scores | Overall handling 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, aged 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 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 40 and 70 years of age (inclusive).
The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye.
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.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
Subjects must own a wearable pair of 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 of more duration).
The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not 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 |
|---|---|---|---|---|---|---|
| Visual Eyes | Roswell | Georgia | 30076 | United States | ||
| ProCare Vision Centers |
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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In total, 42 subjects were enrolled in this study; of which, 41 were randomly assigned into 2 sequences while, 1 subject failed to meet all eligibility criteria. Of the total assigned subjects, 40 subjects completed the study while, 1 subject was discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period. |
| FG001 | Control/Test | Subjects randomized to this sequence received the Control lens during the first period and then received the Test 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 a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects dispensed a 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 | Percentage of Participants With Lens Centration | Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported. | All subjects dispensed at least one study lens. | Posted | Number | Percentage of participants | 6 to 8 days |
|
Throughout the duration of the study. Approximately 2 weeks per subject
All subjects dispensed at least 1 study lens.
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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 | Subjects that wore the Test lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care | 1-800-843-2020 | 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 | Jul 19, 2019 | Dec 10, 2020 | Prot_SAP_000.pdf |
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| Air Optix® Multifocal Contact Lenses Plus HydraGlyde® |
| Device |
CONTROL |
|
| 6 to 8 days |
| Granville |
| Ohio |
| 43023 |
| United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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Subjects that wore the Control lens in either the first or second period of the study.
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|
|
| Primary | Percentage of Participants With Lens Movement | Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported. | All subjects dispensed at least one study lens. | Posted | Number | Percentage of participants | 6 to 8 days |
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| Secondary | Overall Handling Scores | Overall handling 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, aged 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. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | CLUE points | 6 to 8 days |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Control | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 41 | 0 | 41 | 0 | 41 |
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