Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) (DEcIDED)

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease

This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg); Other: ProLong™ collagen plugs

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nancy Gee, MPH; Phone Number: 617-636-5489; Email: ngee@tuftsmedicalcenter.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
      • Contact: Nancy Gee, MPH; Phone Number: 617-636-5489; Email: ngee@tuftsmedicalcenter.org
      • Principal Investigator: Pedram Hamrah, MD
      • Contact: Michael Dixon; Phone Number: 617-636-1051; Email: mdixon3@tuftsmedicalcenter.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Dry Eye Disease
• Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye)
• Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy

Exclusion Criteria:

• History of Diabetes
• History of ocular surgery, corneal infection, or corneal injury within the last 3 months
• Active ocular allergies
• Active ocular infection
• Allergic to benzalkonium chloride

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg); intracanalicular dexamethasone insert	Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg); Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.
Placebo Comparator: ProLong™ collagen plugs; collagen plug	Other: ProLong™ collagen plugs; The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ocular inflammation	As measured by change to dendritic cell density and ocular redness	Change from Baseline one month after intracanalicular insert implantation or punctal plug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Parameter: Ocular Surface Disease Index (OSDI)	12-item scale; score ranges from 0 to 100 and is calculated by the sum of the scores for all 12 questions answered multiplied by 100, which is divided by the total number of questions answered times four	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)	32-questions, 8-domain questionnaire using numerical rating scales to assess eye pain intensity (worse eye) in the past 24 hours and 2 weeks (worst, least and average pain intensity), frequency of eye and non-eye pain (past 24 hours and 2 weeks), non-eye pain intensity (past 24 hours and 2 weeks), impact on QoL, pre-occupation with eye and non-eye pain, aggravating factors and associated factors.)	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)	Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root.	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Tear Break Up Time (TBUT)	The standard TBUT measurement will be performed by dropping a fluorescein drop to the inferior tarsal conjunctiva and waiting 30 seconds. After several blinks, the tear film will be examined. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film will be measured three times and the mean value of the measurements will be calculated.	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Conjunctival staining	Grading of conjunctival lissamine green staining will be performed after 1 minutes of application of a lissamine green drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-18.	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Corneal staining with fluorescein	Corneal fluorescein staining will be performed after 2 minutes of application of a fluorescein drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-15.	Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Schirmer II test	Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes.	Change from Baseline one month after intracanalicular insert implantation or punctal plug

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Inflammation; 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
• Other Study ID Numbers: STUDY00000084

Drug and device information, study documents

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