Clinical trial NCT04413279: Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Eye Surgeons of Indiana
Sponsor class: NETWORK
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-06-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in meibomian gland scores (expressibility and quality)
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12
measure: Patient preference for
timeFrame: Assessed at Week 12
Secondary outcomes:
measure: Mean change in MMP-9
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
measure: Mean change in ocular surface staining
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
measure: Mean change in tear break-up time (TBUT)
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
measure: Mean change in tear osmolarity
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
measure: Mean change in DEQ-5
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
measure: Mean change in Best-corrected Visual Acuity (BCVA)
timeFrame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
Study officials:
affiliation: Eye Surgeons of Indiana
name: Damon Dierker, OD, FAAO
role: PRINCIPAL_INVESTIGATOR
References: