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This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Test Lens) | Experimental | Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear. |
|
| Arm 2 (Control Lens) | Active Comparator | Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Contact Lenses (Test) | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable Lens Fitting | Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported. | Up to 4 Week Follow-up |
| Overall Comfort | Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit. | Up to 4 Week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Family Eyecare | Sarasota | Florida | 34232 | United States | ||
| Eye Associates of Winter Park |
A total of 150 subjects were enrolled in this study. All subjects enrolled into the study were dispensed a study lens. Of the dispensed subjects 146 completed the study and 4 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 entire duration of the study. |
| FG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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 entire duration of the study. |
| BG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the entire duration 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 | Acceptable Lens Fitting | Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Proportion of eyes | Up to 4 Week Follow-up | Subject Eyes | Subject Eyes |
|
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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 entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan, O.D., FAAO Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904 443-1474 | KCANAVA2@its.jnj.com |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| Marketed Contact Lenses (Control) |
| Device |
|
|
| Winter Park |
| Florida |
| 32792 |
| United States |
| Pickens Family Eye Care | Pickens | South Carolina | 29671 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| Torn Lens |
|
| Visit 5 assessments not completed |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
|
|
| Primary | Overall Comfort | Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | Up to 4 Week Follow-up |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Comfilcon A | Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study. | 0 | 75 | 0 | 75 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 3-Week Follow-up |
|
| 4-Week Follow-up |
|