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This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL/CONTROL | Experimental | Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject. |
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| CONTROL/TEST/TEST | Experimental | Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A TEST Lens | Device | senofilcon A with new UV blocker investigational process |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Score | 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported. | 2- Week Follow-up Evaluation |
| Overall Vision Score | 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported. | 2- Week Follow-up Evaluation |
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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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 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 is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW 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's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 (inclusive) in each eye.
The subject's refractive cylinder must be ≤ -1.00 D in each eye.
Have spherocylindrical best corrected visual acuity of 20/25+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 |
|---|---|---|---|---|---|---|
| VRC-West | Foster City | California | 94404 | United States | ||
| Bartram Eye Clinic |
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A total of 92 subjects were enrolled into this study. Of those enrolled, 91 were dispensed a study lens and 1 subject failed to meet the eligibility criteria. Of the dispensed subjects 83 completed the study while 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control/Control | Subjects that wore the Test lens during the first period, the Control lens during the second period and the Control lens again in the third period. |
| FG001 | Control/Test/Test |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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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 | Feb 7, 2018 |
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| senofilcon A CONTROL Lens | Device | senofilcon A with new UV blocker standard process |
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| Jacksonville |
| Florida |
| 32258 |
| United States |
| Pickens Family Eye Care | Pickens | South Carolina | 29671 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| William J. Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
Subjects that wore the Control lens during the first period, the Test lens during the second period and the Test lens again in the third period.
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects 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 | Standard Deviation | 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 | Number | Participants |
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| 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 Score | 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2- Week Follow-up Evaluation |
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| Primary | Overall Vision Score | 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2- Week Follow-up Evaluation |
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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 three study periods. | 0 | 91 | 0 | 91 | 0 | 91 |
| EG001 | Control | Subjects that wore the Control lens during any of the three study periods. | 0 | 91 | 0 | 91 | 0 | 91 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch - Senior Principal Research Optometrist | Johnson & Johnson Vision | 904-443-1707 | JBUCH@its.jnj.com |
| Apr 3, 2019 |
| Prot_SAP_000.pdf |
| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. |
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