Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Lotemax | Other | An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Lotemax | Drug | An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Temperature of Both Eyes | Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays. | baseline, 30 minutes, week 1, week 2 |
| Visual Quality | Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes. | baseline, 30 minutes, week 1, week 2 |
Not provided
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James V Aquavella, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flaum Eye Institute at the University of Rochester | Rochester | New York | 14642 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Administration of 0.5% Lotemax | An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Administration of Lotemax | An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. |
| 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 | Ocular Surface Temperature of Both Eyes | Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays. | Posted | Mean | Standard Deviation | degrees celcius | baseline, 30 minutes, week 1, week 2 |
|
Not provided
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 | Administration of 0.5% Lotemax | An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James V. Aquavella | University of Rochester | 585-276-7439 | rick_barrett@urmc.rochester.edu |
Not provided
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Visual Quality | Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes. | Posted | Mean | Standard Deviation | microns | baseline, 30 minutes, week 1, week 2 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| week 2 |
|