Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | etafilcon A contact lens being worn 7 days/6 nights. |
|
| Test | Experimental | galyfilcon A contact lens being worn 7 days/6 nights. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device |
| ||
| galyfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit. | Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks |
| Rate of Contact Lens Related Serious and Significant Events (SSE) | The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic. | Throughout the duration of the study (1 Year) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steven S. Grant, OD | Costa Mesa | California | 92626 | United States | ||
| Cole, Cole, and Krohn |
504 Subjects were enrolled in this study. 1 subject did not meet the eligibility. 2 subjects were randomized to the control lens group, but were not dispensed lenses. 247 subjects were randomized to the Control lens and 254 subjects were randomized to the Test lens.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control: Etafilcon A | Subjects that were randomly assigned to wear Control lens. |
| FG001 | Test: Galyfilcon A | Subjects that were randomly assigned to wear the Test lens. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fresno |
| California |
| 93704 |
| United States |
| Fukai and Associates | Louisville | Colorado | 80027 | United States |
| Peter C. Donshik, MD | Bloomfield | Connecticut | 06002 | United States |
| Dr. Ted Brink and Associates | Jacksonville | Florida | 32256 | United States |
| Jack J. Yager, OD | Orlando | Florida | 32803 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Eyecare Associates | Bloomington | Illinois | 61701 | United States |
| Drs. Hawks, Besler & Rogers | Gardner | Kansas | 66030 | United States |
| Lee Rigel | East Lansing | Michigan | 48823 | United States |
| Univ Missouri at St. Louis, College of Optometry | St Louis | Missouri | 63121 | United States |
| InSight Eyecare | Warrensburg | Missouri | 64093 | United States |
| Drs. Quinn, Quinn and Associates | Athens | Ohio | 45701 | United States |
| Central Ohio Eyecare | Columbus | Ohio | 43202 | United States |
| Kenji Hamada, OD | Grants Pass | Oregon | 97526 | United States |
| West Hills Vision Center | Moon Township | Pennsylvania | 15108 | United States |
| Kenneth A. Young, OD | Brentwood | Tennessee | 37027 | United States |
| Gary W. Jerkins, MD | Nashville | Tennessee | 37205 | United States |
| Premier Vision | Amarillo | Texas | 79119 | United States |
| Charles Wegman, OD | Carrollton | Texas | 75006 | United States |
| Wishnow-Sugar Vision Group | Katy | Texas | 77450 | United States |
| First Eye Care Plano | Plano | Texas | 75023 | United States |
| Dr. William Bogus | Salt Lake City | Utah | 84106 | United States |
| Scott Jens, OD | Middleton | Wisconsin | 53562 | United States |
| Snowy Range Vision Center | Laramie | Wyoming | 82070 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline population consists of subjects that were randomized to receive either the Test or Control lens.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control: Etafilcon A | Subjects that were randomized to receive the Control lens etafilcon A |
| BG001 | Test: Galyfilcon A | Subjects that were randomized to receive the Test lens galyfilcon A |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit. | The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes. | Posted | Number | Percentage of Subjects Eyes | Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks | Eyes | Participants |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Rate of Contact Lens Related Serious and Significant Events (SSE) | The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic. | All subjects that were dispensed a study lens. | Posted | Number | percentage of Subjects | Throughout the duration of the study (1 Year) |
|
|
Throughout the duration of the Study (1 Year)
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 | Control: Etafilcon A | Subjects that were randomly assigned to wear Control lens. | 0 | 247 | 23 | 247 | ||
| EG001 | Test: Galyfilcon A | Subjects that were randomly assigned to wear Test lens. | 1 | 254 | 43 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IRITIS | Eye disorders | Inflammation of the iris. This was classified as unrelated to the study lens. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | Includes Bacterial, Viral, Allergic, Contact-lens Papillary, Kerato, and Unspecified Conjunctivitis. |
| ||
| CLPU | Eye disorders | Contact Lens Peripheral Ulcer |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David C. Turner, Ph.D. GLOBAL PLATFORM SR DIRECTOR, R&D | Johnson & Johnson Vision Care, Inc. | 904-443-3500 | 3479 | DTURNER2@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| White |
|
| African-American |
|
| Hispanic |
|
| Asian-Indian |
|
| Other |
|
| 4-week Follow-up, N=392, 370 |
|
| 12-week Follow-up, N=388, 370 |
|
| 24-week Follow-up, N=390, 370 |
|
| 36-week Follow-up, N=390 , 365 |
|
| 52-week Follow-up, N=390, 368 |
|
|