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This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL/CONTROL | Experimental | Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL) |
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| CONTROL/TEST/TEST | Experimental | Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTROL | Device | ACUVUE OASYS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort 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. The average comfort score from the 3 study periods was reported. | 2-Week Follow-up |
| Distance Monocular LogMAR Visual Acuity | Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported. | 2-Week Follow-up |
| Contact Lens Fitting Acceptance Rate | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type. | Up to 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported. |
| 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. The average vision score from the 3 study periods was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following inclusion criteria to be enrolled in the study:
The subject must read and sign the Informed Consent form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D).
The subject's refractive cylinder must be ≤ 1.00D in each eye.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
Subjects must own a wearable pair of spectacles.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
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 |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates, PA | Jacksonville | Florida | 32205 | United States | ||
| Vue Optical Boutique |
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A total of 133 subjects were enrolled into this study. Of the enrolled subjects, 130 were dispensed at least one study lens and 3 subjects failed to meet all eligibility criteria. Of the dispensed subjects 127 completed the study while 3 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control/Control | Subjects that wore the Test lens during the first period, and the control lens during the second and third period of the study. |
| FG001 | Control/Test/Test | Subjects that wore the Control lens during the first period and the Test lens during the second and third period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were 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 | Overall Comfort | Overall comfort 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. The average comfort score from the 3 study periods was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
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Throughout the entire duration of the study. Approximately 6 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 | Test | Subjects that wore the Test lens during any of the 3 periods of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch -SENIOR PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care Inc. | 904 443-1707 | JBUCH@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 | Jun 14, 2017 | Sep 14, 2018 | Prot_SAP_000.pdf |
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| TEST |
| Device |
senofilcon A with new UV blocker |
|
| Up to 2-Week Follow-up |
| 2-Week Follow-up |
| Overall Handling | 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, 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. The average handling score from the 3 study periods was reported. | 2-Week Follow-up |
| Jacksonville |
| Florida |
| 32250 |
| United States |
| VisionCare Associates | East Lansing | Michigan | 48823 | United States |
| Pickens Family Eye Care | Pickens | South Carolina | 29671 | United States |
| William J. Bogus, OD | Salt Lake City | Utah | 84106 | United States |
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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 | Count of Participants | Participants |
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| OG001 | Control | Subjects that wore the Control lens during any of the 3 periods of the study. |
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| Primary | Distance Monocular LogMAR Visual Acuity | Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up | Eyes | Eyes |
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| Primary | Contact Lens Fitting Acceptance Rate | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type. | Subjects that completed all study visits. | Posted | Number | proportion of eyes | Up to 2-Week Follow-up | eyes | eyes |
|
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| Primary | 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported. | Subjects that were dispensed at least one study lens. | Posted | Number | Slit Lamp Finding | Up to 2-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. The average vision score from the 3 study periods was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
|
|
|
|
| Secondary | Overall Handling | 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, 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. The average handling score from the 3 study periods was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
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| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | Control | Subjects that wore the Control lens during any of the 3 periods of the study. | 0 | 130 | 0 | 130 | 0 | 130 |
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| Non-Inferiority |
A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference. |
| Non-Inferiority |
A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5% |