Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PROD-502 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| narafilcon A / etafilcon A - etafilcon A - narafilcon A | Experimental | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. |
|
| narafilcon A / etafilcon A - narafilcon A - etafilcon A | Experimental | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. |
|
| narafilcon A - etafilcon A - narafilcon A / etafilcon A | Experimental | First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
|
| etafilcon A - narafilcon A - narafilcon A / etafilcon A | Experimental | First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes Successfully Fit | Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'. | Within 20 minutes of lens insertion |
| Lens Fit Decentration | Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm. | Within 20 minutes of lens insertion |
| Lens Tightness on Cornea With Manual Digit Push Up | Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement. | Within 20 minutes of lens insertion |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visioncare Research Ltd | Farnham | Surrey | GU9 7EN | United Kingdom |
Subjects were enrolled per inclusion/exclusion criteria and randomized to a study arm.
There were 25 subjects enrolled to the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. |
| FG001 | Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. |
| FG002 | Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A | First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
| FG003 | Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A | First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One |
| |||||||||||||
| Period Two |
| |||||||||||||
| Period Three |
|
All enrolled and completed subjects were included in the baseline summary.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who enrolled and completed 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 | Proportion of Eyes Successfully Fit | Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'. | Participants who were enrolled and completed the study. | Posted | Number | proportion of participant eyes | Within 20 minutes of lens insertion | eyes | Participants |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody OD FAOO / Director | Vistakon | 904-443-3088 |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| narafilcon A | Device | contact lens |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Narafilcon A worn in either eye. |
| OG002 | Etafilcon A (Bilateral) | Etafilcon A contact lens worn in both eyes. |
| OG003 | Etafilcon A (Contralateral) | Etafilcon A worn in either eye. |
|
|
| Primary | Lens Fit Decentration | Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm. | Participants who were enrolled and completed the study. | Posted | Mean | Standard Deviation | mm | Within 20 minutes of lens insertion | eye | Participants |
|
|
|
| Primary | Lens Tightness on Cornea With Manual Digit Push Up | Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement. | Participants who were enrolled and completed the study. | Posted | Mean | Standard Deviation | percentage | Within 20 minutes of lens insertion | eye | Participants |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. | 0 | 7 | 0 | 7 |
| EG002 | Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A | First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. | 0 | 4 | 0 | 4 |
| EG003 | Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A | First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. | 0 | 2 | 0 | 2 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
| eye |
|