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This study compares the performance of an investigational contact lens to a currently marketed lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens | Experimental | galyfilcon A contact lens with a silver additive |
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| Control Lens | Active Comparator | galyfilcon A control contact lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyifilcon A control lens | Device | Marketed daily wear contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported. | 6 months |
| Subject Reported Symptoms | Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported. | 6 months |
| Visual Acuity | Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts. | 6 months |
| Average Contact Lens Wear Time | The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cole, Cole, and Krohn | Fresno | California | 93704 | United States | ||
| Dr. James R. Dugue Family Optometrist |
A total of 529 subjects were enrolled in this study. Of those enrolled subjects, 33 did not meet the eligibility criteria and 496 were randomized to either the test or control lens using a 2:1 allocation. Of those randomized subjects 491 were successfully dispensed. Of the dispensed subjects 454 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A w/ Silver | Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study. |
| FG001 | Galyfilcon A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| galyfilcon A with a silver additive | Device | Investigational daily wear contact lens |
|
| Mission Viejo |
| California |
| 92691 |
| United States |
| Fukai and Associates | Louisville | Colorado | 80027 | United States |
| Baymeadows Vision Center | Jacksonville | Florida | 32256 | United States |
| Eyecare Associates | Bloomington | Illinois | 61701 | United States |
| Advantage Eyecare Associates, LLC | Neodesha | Kansas | 66757 | United States |
| InSight Eyecare | Warrensburg | Missouri | 64093 | United States |
| Spectrum Eyecare | Jamestown | New York | 14750 | United States |
| Drs. Quinn, Quinn and Associates | Athens | Ohio | 45701 | United States |
| Dr. Michael H. Greenburg, Inc. | Chagrin Falls | Ohio | 44023 | United States |
| Central Ohio Eyecare | Columbus | Ohio | 43202 | United States |
| James W. Kershaw OD, Inc. | North Olmsted | Ohio | 44070 | United States |
| West Hills Vision Center | Moon Township | Pennsylvania | 15108 | United States |
| Nittany Eye Associates | State College | Pennsylvania | 16801 | United States |
| Research Across America | Wyomissing | Pennsylvania | 19610 | United States |
| Dr. David W. Ferris and Associates | Warwick | Rhode Island | 02886 | United States |
| Premier Vision | Amarillo | Texas | 79119 | United States |
| William J. Bogus OD | Salt Lake City | Utah | 84106 | United States |
| The Eye Speciliasts, Ltd | Virginia Beach | Virginia | 23455 | United States |
| Snowy Range Vision Center | Laramie | Wyoming | 82070 | United States |
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
| COMPLETED |
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| NOT COMPLETED |
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All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galyfilcon A w/ Silver | Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study. |
| BG001 | Galyfilcon A | Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study. |
| BG002 | Total | Total of all reporting groups |
| 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| 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 | Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Number | Number of Subject Eyes | 6 months | Subject Eyes | Participants |
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| Primary | Subject Reported Symptoms | Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Observations | 6 months | Number of Observations | Participants |
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| Primary | Visual Acuity | Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 6 months |
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| Primary | Average Contact Lens Wear Time | The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Full Range | time in hours | 6 Months |
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Throughout the duration of the study. Approximately 6 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 | Galyfilcon A w/ Silver | Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study. | 0 | 326 | 0 | 326 | ||
| EG001 | Galyfilcon A | Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study. | 1 | 165 | 0 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iritis | Eye disorders | Note from Dr. Not Lens Related. Possible Cause: "Iritis secondary to cornea culture" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 1290 | BPALL@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| White |
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| African American |
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| Native American |
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| Asian - Indian |
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| Hispanic |
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| Other |
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| Number of Observations |
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