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.
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
To manage patients with dry eye disease secondary to MGD
to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Change from baseline in meibomian gland scores (expressibility and quality)
As measured on a grading scale 1 to 4 and graded by the physician
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12
Patient preference for
As measured by COMTOL Survey
Time frame: Assessed at Week 12
Mean change in MMP-9
As measured by InflammaDry
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in ocular surface staining
As measured by sodium fluorescein and lissamine green
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear break-up time (TBUT)
As measured by TBUT testing
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear osmolarity
As measured by TearLab
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
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.
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in Best-corrected Visual Acuity (BCVA)
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As measured by ETDRS chart
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit