Sjogren's Disease
Conditions
Keywords
Non-invasive instruments, Environment, Wavefront, Placido Disk, Ellipsometer, Thermal Imaging
Brief summary
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).
Interventions
DRUGAdministration of Lotemax
An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.
Sponsors
Bausch & Lomb Incorporated
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-70 * Diagnosed with Sjogren's Disease * Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI) * Ability to give informed consent * Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits * Either gender * Any racial or ethnic origin
Exclusion criteria
* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s). * Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection. * Subjects who have had cataract surgery less than one year ago * Use of soft or hard contact lenses. * Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions). * Inability to provide analyzable data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Temperature of Both Eyes | baseline, 30 minutes, week 1, week 2 | 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. |
| Visual Quality | baseline, 30 minutes, week 1, week 2 | Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Administration of Lotemax An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Administration of Lotemax |
|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 4.92 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: baseline, 30 minutes, week 1, week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Administration of 0.5% Lotemax | Ocular Surface Temperature of Both Eyes | baseline | 33.95 degrees celcius | Standard Deviation 0.13 |
| Administration of 0.5% Lotemax | Ocular Surface Temperature of Both Eyes | 30 minutes | 34.3 degrees celcius | Standard Deviation 0.13 |
| Administration of 0.5% Lotemax | Ocular Surface Temperature of Both Eyes | week 1 | 33.93 degrees celcius | Standard Deviation 0.12 |
| Administration of 0.5% Lotemax | Ocular Surface Temperature of Both Eyes | week 2 | 33.95 degrees celcius | Standard Deviation 0.13 |
Primary
Visual Quality
Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.
Time frame: baseline, 30 minutes, week 1, week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Administration of 0.5% Lotemax | Visual Quality | baseline | 0.48 microns | Standard Deviation 0.04 |
| Administration of 0.5% Lotemax | Visual Quality | 30 minutes | 0.54 microns | Standard Deviation 0.04 |
| Administration of 0.5% Lotemax | Visual Quality | week 1 | 0.49 microns | Standard Deviation 0.08 |
| Administration of 0.5% Lotemax | Visual Quality | week 2 | 0.48 microns | Standard Deviation 0.04 |