Dry Eye Syndromes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELipiFlow Thermal Pulsation
To manage patients with dry eye disease secondary to MGD
DRUGDexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation
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
Sponsors
Ocular Therapeutix, Inc.
Eye Surgeons of Indiana
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in meibomian gland scores (expressibility and quality) | Assessed at Baseline, Week 1, Week 4 and Week 12 | As measured on a grading scale 1 to 4 and graded by the physician |
| Patient preference for | Assessed at Week 12 | As measured by COMTOL Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in tear break-up time (TBUT) | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | As measured by TBUT testing |
| Mean change in tear osmolarity | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | As measured by TearLab |
| Mean change in MMP-9 | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | As measured by InflammaDry |
| Mean change in Best-corrected Visual Acuity (BCVA) | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | As measured by ETDRS chart |
| Mean change in DEQ-5 | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 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. |
| Mean change in ocular surface staining | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | As measured by sodium fluorescein and lissamine green |
Countries
United States
Outcome results
None listed