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To evaluate the impact of a new contact lens hydration process
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, senofilcon A | Active Comparator | Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study. |
|
| Test, senofilcon A | Experimental | Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | Control, senfilcon A |
| |
| senofilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Comfort (Using CLUE ) | Contact Lens User Experience Comfort scores (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. | 2 weeks |
| Subjective Overall Vision (Using CLUE ) | Contact Lens User Experience Vision scores (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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pall, OD | Johnson & Johnson Vision Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | 32256 | United States | |||
A total of 136 subjects were enrolled in the study; 9 subjects did not meet the inclusion and exclusion criteria and not randomized. Of the 127 randomized subjects, 6 were prematurely discontinued from the study and 2 were excluded from the analysis due to major protocol deviations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control/Test | Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study. |
| FG001 | Test/Control | Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| |||||||||||||||||||||
| Second Intervention |
|
This includes all randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Control/Test | Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study. |
| BG001 | Test/Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Subjective Overall Comfort (Using CLUE ) | Contact Lens User Experience Comfort scores (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. | Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
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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 | Control, Senofilcon A | Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jurandir Araujo | Clinical Compliance Manager | 904 443-1379 | jaraujo7@jnj.com |
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| Device |
Test, senofilcon A |
|
| Bloomington |
| Illinois |
| 61701 |
| United States |
| Pittsburg | Kansas | 66762 | United States |
| Warwick | Rhode Island | 02888 | United States |
| Physician Decision |
|
| NOT COMPLETED |
|
|
Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Test, Senofilcon A | Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study. |
|
|
| Primary | Subjective Overall Vision (Using CLUE ) | Contact Lens User Experience Vision scores (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. | Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Test, Senofilcon A | Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study, | 0 | 63 | 0 | 63 |
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