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This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | The lenses will be worn for 2 hours in both eyes, and not dispensed |
|
| lotrafilcon A | Active Comparator | The lenses will be worn for 2 hours in both eyes, and not dispensed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | A soft spherical contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion |
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion |
| Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelvin Grove | Queensland | 4059 | Australia |
A total of 25 subjects were enrolled into this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 21 were dispensed study lenses. Of the dispensed subjects all 21 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Lotrafilcon B | Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens. |
| FG001 | Lotrafilcon B/Senofilcon A | Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
All subjects that were dispensed at least 1 study lens throughout the duration of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed | All subjects that were dispensed at least 1 study lens during the course of the 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 | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | All subjects that have completed all study visits. | Posted | Mean | Standard Deviation | microns | 2 hours post insertion |
|
Throughout the duration of the study. Approximately 1-week 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 | Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care Inc. | 904-443-3449 | CColesb@ITS.JNJ.com |
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| lotrafilcon B |
| Device |
|
| NOT COMPLETED |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
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|
| Primary | Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | All subjects that have completed all study visits. | Posted | Mean | Standard Deviation | microns | 2 hours post insertion |
|
|
|
| Primary | Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | All subjects that have completed all study visits. | Posted | Mean | Standard Deviation | microns | 2 hours post insertion |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Lotrafilcon B | Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study. | 0 | 21 | 0 | 21 |
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