Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

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

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Lifitegrast 5% Ophthalmic Solution; Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46040
      • Eye Surgeons of Indiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xiidra Only Group; Patients with dry eye disease Xiidra only	Drug: Lifitegrast 5% Ophthalmic Solution; To reduce signs and symptoms of dry eye disease; Other Names: Xiidra
Experimental: Xiidra + Dextenza Group; Patients with dry eye disease Xiidra + Dextenza	Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution; To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.; Other Names: Dextenza; Xiidra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in ocular surface staining	As measured by sodium fluorescein and lissamine green	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Patient Preference for therapy	As measured by COMTOL Survey	Assessed at Week 12 Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in MMP-9	As measure by InflammaDry	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean change in tear break-up time (TBUT)	As measured by TBUT testing	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean change in conjunctival injection	As measured on a scale of 0-4 and graded by the physician	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
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 2, Week 4 and Week 12 Visit
Mean change in tear osmolarity	As measured by Tear Lab	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean change in DEQ-5	As measured by the DEQ-5 Questionnaire	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean change in Best-corrected Visual Acuity (BCVA)	As measure by ETDRS	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

Collaborators and Investigators

• Sponsor: Eye Surgeons of Indiana
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Ophthalmic Solutions; Pharmaceutical Solutions; Lifitegrast
• Other Study ID Numbers: The DAMON Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No