Dry Eye Syndromes
Conditions
Brief summary
To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management
Detailed description
This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.
Interventions
all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion
OTHEROver the counter Artificial tears
over the counter artificial tears PRN at patient discretion
Sponsors
The Eye Centers of Racine and Kenosha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * Age 18 years and older * Demonstrate objective signs of Ocular Surface Disease (OSD) or * Demonstrate symptoms of OSD determined by a standardized questionnaire * No other corneal pathology to create unknown variability
Exclusion criteria
A patient who meets any of the following criteria in either eye will be excluded from the study: * History of using topical steroids or other anti-inflammatory drops within 6 months of the study * History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months * History or current use of oral steroids or immunosuppressants * Active ocular infection * History of HSV * History corneal refractive surgery * Uncontrolled Glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine effect of dexamethasone insert over artificial tears | 1 month | To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OSDI scores | 1 month | comfort of dry eyes using the OSDI scale and reading scores, scores are from the SPEED questionnaire. scale from 0-3 0-Never 1- Sometime 2-Often 3-Constant for the symptoms |
Other
| Measure | Time frame | Description |
|---|---|---|
| ITRACE | 1 month | measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any |
| IOL Master | 1 month | as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit |
Countries
United States
Outcome results
None listed