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Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.
Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon C | Experimental | JJVCI investigational contact lens daily wear replacement. |
|
| comfilcon A | Active Comparator | Marketed contact lens daily wear replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon C | Device | Investigational contact lens |
| |
| comfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported. | Up to 3 Month Follow-up |
| Visual Acuity | Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported. | Up to 3 month Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported. | Up to 3 month Follow-up |
| Average Wear Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Omega Vision Center, PA / Sabal Eye Care |
A total of 224 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 221 were dispensed a study lens. Of the dispensed subjects 204 completed the study while 17 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon C | Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study. |
| FG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
Marketed Monthly Replacement Lens (Control) |
|
|
Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported. |
| 3 month Follow-up |
| Longwood |
| Florida |
| 32779 |
| United States |
| Eyecare Associates | Bloomington | Illinois | 61701 | United States |
| Advantage Eyecare Associates, LLC | Broadway Pittsburg | Kansas | 66762 | United States |
| Dr. Debbie H. Kim, OD | Closter | New Jersey | 07624 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Pickens Family Eye Care | Pickens | South Carolina | 29671 | United States |
| Premier Vision | Amarillo | Texas | 79119 | United States |
| William J. Bogus OD | Salt Lake City | Utah | 84106 | United States |
| Timothy R. Poling, OD | Salem | Virginia | 24153 | United States |
| 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 | Senofilcon C | Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study. |
| BG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study. |
| 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported. | All subjects that were dispensed a study lens. | Posted | Number | Eyes | Up to 3 Month Follow-up | Subject Eyes | Participants |
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| Primary | Visual Acuity | Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | Up to 3 month Follow-up | Number of Observations | Participants |
|
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| Secondary | Symptoms | Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported. | All subjects that were dispensed a study lens. | Posted | Number | Eyes | Up to 3 month Follow-up | Subject Eyes | Participants |
|
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| Secondary | Average Wear Time | Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Hours per day | 3 month Follow-up |
|
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Throughout the entire duration of the study. Approximately 5 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 | Senofilcon C | Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study. | 0 | 109 | 5 | 109 | ||
| EG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study. | 0 | 112 | 5 | 112 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Significant Ocular Event | Eye disorders | Includes Localized allergic reaction, allergic conjunctivitis, solution sensitivity allergic keratoconjunctivitis, Contact lens papillary conjunctivitis, symptoms of problems requiring treatment, Blepharoconjunctivitis, non-significant infiltrate |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan, O.D., F.A.A.O. Principle Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-1474 | KCANAVA2@its.jnj.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Number of Observations |
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| Subject Eyes |
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