Dry Eye Syndromes Clinical Trial
Official title:
Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation
Verified date | April 2022 |
Source | Eye Surgeons of Indiana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: - 18 years of age or older - Evaporative DED with MGD and clinically significant inflammation - Willing and able to comply with clinic visits and study related procedures - Willing and able to sign the informed consent form Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: - Patients under the age of 18. - Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) - Active infectious systemic disease - Active infectious ocular or extraocular disease - Altered nasolacrimal flow of either acquired, induced, or congenital origin - Hypersensitivity to dexamethasone - Patient being treated with either topical, oral, or intravenous steroids - Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator |
Country | Name | City | State |
---|---|---|---|
United States | Eye Surgeons of Indiana | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Eye Surgeons of Indiana | Ocular Therapeutix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in meibomian gland scores (expressibility and quality) | As measured on a grading scale 1 to 4 and graded by the physician | Assessed at Baseline, Week 1, Week 4 and Week 12 | |
Primary | Patient preference for | As measured by COMTOL Survey | Assessed at Week 12 | |
Secondary | Mean change in MMP-9 | As measured by InflammaDry | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | |
Secondary | Mean change in ocular surface staining | As measured by sodium fluorescein and lissamine green | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | |
Secondary | Mean change in tear break-up time (TBUT) | As measured by TBUT testing | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | |
Secondary | Mean change in tear osmolarity | As measured by TearLab | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | |
Secondary | Mean change in DEQ-5 | As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms. | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | |
Secondary | Mean change in Best-corrected Visual Acuity (BCVA) | As measured by ETDRS chart | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit |
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