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This study is a randomized, single-masked, crossover clinical trial. There are two study lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur. The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens pair will occur. The second study lenses will then be fit and the above sequence repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Test/Control. |
|
| Control/Test | Experimental | Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Control/Test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJV Investigational Multifocal Contact Lens | Device | TEST |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | 2-Week Follow-up |
| Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | 2-Week Follow-up |
| Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision Scores | Overall vision scores were 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 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 at least 40 years of age and not greater than 70 years of age at the time of consent.
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 or 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" (Appendix E).
The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 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 distance best corrected visual acuity of 20/20-3 or better in each eye.
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 |
|---|---|---|---|---|---|---|
| Maitland Vision Center | Maitland | Florida | 32751 | United States | ||
| Advanced Eyecare |
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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A total of 46 subjects were enrolled in this study. Of those enrolled, 44 (95.7%) subjects randomized and dispensed at least 1 study lens while, 2 (4.3%) subjects failed to meet all eligibility criteria. Of those dispensed, 43 (93.5%) subjects completed the study while, 1 (2.2%) 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 |
| |||||||||||||
| Period 2 |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Subjects that wore either Test or Control lens in either first or second period of the study. |
| 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 | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
|
Throughout the duration of the study. Approximately 21-28 days 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. | Johnson & Johnson Vision Care, Inc. | 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 | Oct 25, 2019 | Mar 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 1-Day Acuvue® Moist Brand Multifocal Contact Lens |
| Device |
CONTROL |
|
| 2-Week Follow-up |
| Overall Comfort Scores | Overall comfort scores were 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. | 2-Week Follow-up |
| Number of Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported. | 2-Week Follow-up |
| Proportion of Subjects That Reported Ocular Symptoms | Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type. | 2-Week Follow-up |
| Raytown |
| Missouri |
| 64133 |
| United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Frazier Vision Inc. | Jacksonville | Texas | 75703 | United States |
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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 | Count of Participants | Participants |
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| OG001 | Control (Etafilcon A) | Subjects that wore the Control lens in either the first or second period of the study. |
|
|
| Secondary | Overall Vision Scores | Overall vision scores were 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. | Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | CLUE points | 2-Week Follow-up |
|
|
|
| Secondary | Overall Comfort Scores | Overall comfort scores were 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. | Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | CLUE points | 2-Week Follow-up |
|
|
|
| Secondary | Number of Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported. | Analysis population consisted of all subjects who were dispensed at least 1 study lens. | Posted | Number | number of eyes | 2-Week Follow-up | number of eyes | number of eyes |
|
|
|
| Secondary | Proportion of Subjects That Reported Ocular Symptoms | Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type. | Analysis population consisted of all subjects who were dispensed at least 1 study lens. | Posted | Number | proportion | 2-Week Follow-up | number of eyes | number of eyes |
|
|
|
| Primary | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
|
|
|
| Primary | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. | Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Control | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 44 | 0 | 44 | 0 | 44 |
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| Standard High Contrast Dim with Goggles: Near |
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| Standard Low Contrast Bright: Near |
|