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Evaluation of Comfilcon A and Senofilcon A Lenses
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senofilcon A | Active Comparator | Senofilcon A; Comfilcon A |
|
| Comfilcon A | Experimental | Comfilcon A; Senofilcon A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senofilcon A; Comfilcon A | Device | Senofilcon A; Comfilcon A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever) | Baseline Insertion, 10 Minutes, 5 hours and 10 hours |
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Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
Has had an oculo-visual examination in the last two years
Is at least 18 years of age and has full legal capacity to volunteer
Has read and understood the information consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Currently wears soft contact lenses at least 3 days a week, 8 hours a day
Has clear corneas and no active ocular disease
Has not worn lenses for at least 12 hours before the examination
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Bergmanson, OD, PhD | University of Houston College of Optometry, TERTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry, TERTC | Houston | Texas | 77204 | United States |
Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Participants | Senofilcon A and Comfilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | Senofilcon A and Comfilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever) | Posted | Mean | Standard Deviation | units on a scale | Baseline Insertion, 10 Minutes, 5 hours and 10 hours |
|
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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 | Overall Study Participants | Senofilcon A and Comfilcon A |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Bergmanson, OD,PhD | University of Houston, College of Optometry, TERTC | 713-743-1950 | jbergmanson@uh.edu |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Comfilcon A; Senofilcon A |
| Device |
Comfilcon A; Senofilcon A |
|
| eyes |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Comfilcon A | Comfilcon A / CooperVision Biofinity Sphere | 0 | 61 | 0 | 61 |
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