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Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Contact Lens with UV Blocker | Experimental | Subjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. |
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| Marketed Contact Lens | Active Comparator | Subjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A with new UV blocker | Device | Investigational Contact Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Eyestrain Related to Glare | Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory. | Up to 12-Week Follow-up |
| Distance Monocular logMAR Visual Acuity (VA) | Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision. | Up to 12-Week Follow-up |
| Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point. | Up to 12-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Wearing Time | Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported. | Up to 12-Week Follow-up |
| Percentage of Eyes With Subject Reported Symptoms Problems or Complaints |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | 32205 | United States | |||
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A total of 133 subjects were enrolled into the study. Of the enrolled subjects 131 were dispensed study lenses and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects 123 completed the study and 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A With New UV Blocker | Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study. |
| FG001 | Senofilcon A | Subjects that wore the senofilcon A lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A With New UV Blocker | Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study. |
| BG001 | Senofilcon A | Subjects that wore the senofilcon A lens throughout the entire duration of the study. |
| 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 | Eyestrain Related to Glare | Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 12-Week Follow-up |
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Throughout the entire duration of study lens wear. Approximately 12-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 | Senofilcon A With New UV Blocker | Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch- SENIOR PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2016 | May 7, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 13, 2016 | May 7, 2018 | Prot_001.pdf |
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| senofilcon A | Device | J&J Marketed Contact Lens |
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Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point. |
| Up to 12-Week Follow-up |
| Longwood |
| Florida |
| 32779 |
| United States |
| Sarasota | Florida | 34242 | United States |
| Closter | New Jersey | 07624 | United States |
| Vestal | New York | 13850 | United States |
| Pickens | South Carolina | 29671 | United States |
| Adverse Event |
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| Lens Discomfort |
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| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| 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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| OG001 | Senofilcon A (Control) | Subjects that wore the senofilcon A lens for the first 12 weeks of the study. |
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| Primary | Distance Monocular logMAR Visual Acuity (VA) | Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | Up to 12-Week Follow-up | Eyes | Eyes |
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| Primary | Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point. | All subjects that were dispensed at least one study lens. | Posted | Number | Percentage of eyes | Up to 12-Week Follow-up | Eyes | Eyes |
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| Secondary | Contact Lens Wearing Time | Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours | Up to 12-Week Follow-up |
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| Secondary | Percentage of Eyes With Subject Reported Symptoms Problems or Complaints | Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point. | All subjects that were dispensed at least one study lens. | Posted | Number | Percentage of eyes | Up to 12-Week Follow-up | Eyes | Eyes |
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| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Senofilcon A | Subjects that wore the senofilcon A lens throughout the entire duration of the study. | 0 | 64 | 0 | 64 | 0 | 64 |
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| 8-Week Follow-up |
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| 12-Week Follow-up |
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| 8-Week Follow-up |
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| 12-Week Follow-up |
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| 8-Week Follow-up |
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| 12-Week Follow-up |
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| 4-Week Follow-up |
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| 8-Week Follow-up |
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| 12-Week Follow-up |
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