Clinical trial NCT04413253: Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
Official title: Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: 5
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 patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

Detailed description: This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

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
* Signs and symptoms of DED
* Consent to treat with topical immunomodulator
* 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
* Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
* Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Primary outcomes:
measure: Mean change in ocular surface staining
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Patient Preference for therapy
timeFrame: Assessed at Week 12 Visit
Secondary outcomes:
measure: Mean change in MMP-9
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Mean change in tear break-up time (TBUT)
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Mean change in conjunctival injection
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Change from baseline in meibomian gland scores (expressibility and quality)
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Mean change in tear osmolarity
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Mean change in DEQ-5
timeFrame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
measure: Mean change in Best-corrected Visual Acuity (BCVA)
timeFrame: Assessed at Baseline, Week 1, Week 2, 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: