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The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Test Control Test | Active Comparator | Test/control/test using the Johnson & Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn. |
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| Sequence 2: Control Test Control | Active Comparator | Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Marketed Contact Lens (Test) | Device |
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| 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively. | 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Becky Bizzle, OD | Montgomery | Alabama | 36117 | United States | ||
| Complete Family Eye Care of Fruit Cove |
A total of 286 subjects were enrolled in this study. Of the enrolled subjects 1 subject did meet the eligibility criteria and 285 subjects were randomized. Of the randomized subjects 9 were discontinued and 276 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A /Senofilcon A/Delefilcon A | Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third. |
| FG001 | Senofilcon A/Delefilcon A/Senofilcon A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Competitor Marketed Contact Lens (Control) | Device |
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| Fruit Cove |
| Florida |
| 32259 |
| United States |
| Golden Family Eyecare | Sarasota | Florida | 34232 | United States |
| St. Lucy's Vision Center | Tampa | Florida | 33625 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| VisualEyes, Inc. | Roswell | Georgia | 30076 | United States |
| Advantage Eyecare Associates, LLC | Neodesha | Kansas | 66757 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Advanced Family Eye Care | Denver | North Carolina | 28037 | United States |
| total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| Brian Frazier, OD | Jacksonville | Texas | 17576 | United States |
| Timothy R. Poling, OD | Roanoke | Virginia | 24153 | United States |
| Ziegler Leffingwell Eyecare | West Allis | Wisconsin | 53227 | United States |
Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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All subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one study lens throughout the 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 | 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 | 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively. | The analysis population consists of subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 1 Week | Number of Observations | Number of Observations |
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Throughout the duration of the study. Approximately 3 months.
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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 | Delefilcon A | Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study. | 0 | 285 | 0 | 285 | ||
| EG001 | Senofilcon A | Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study. | 0 | 285 | 0 | 285 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S., F.A.A.O - Senrior Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-1290 | BPALL@its.jnj.com |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Received Incorrect Treatment at period 3 |
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| Black or African American |
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| White |
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| Other |
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