Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | Acuvvue Oasys with Hydaclear Plus with 38% water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE) | CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120. | Post 3 days of wear |
| Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers. | Post 3 days of wear |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fullerton | California | 92831 | United States |
A total of 64 subjects were enrolled in this study. Of the enrolled subjects 2 did not meet the eligibility criteria and 62 were dispensed a study lens. Of the dispensed subjects 60 completed the study and 2 were discontinued.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall | Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
64 subjects enrolled with 60 Completing
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed the study lens. |
| 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 | Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE) | CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120. | Subjects are those who were enrolled, randomized, and completed the study per protocol. | Posted | Mean | Standard Deviation | units on a scale | Post 3 days of wear |
|
|
Data was collected over the course of the study, approximately 1 week.
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 | Senofilcon A, 38% Water | Senofilcon A, 38% water |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daria Wicks | Vistakon | 904-443-1391 | RA-VISUS-ClnclStds@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers. | Subjects analyzed are those who enrolled, randomized, and completed the study per protocol. | Posted | Number | eyes | Post 3 days of wear | Eyes | Eyes |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
Not provided
| Title | Measurements |
|---|
|
| Grade 3 |
|