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

NCT04527887 | Terminated Phase 4 FDA Drug

• 1 other identifier: STUDY00000084
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical Parameter: Ocular Surface Disease Index (OSDI)

  Change from Baseline one month after intracanalicular insert implantation or punctal plug

• Clinical Parameter: Ocular Pain Assessment Survey (OPAS)

  Change from Baseline one month after intracanalicular insert implantation or punctal plug

• Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)

  Change from Baseline one month after intracanalicular insert implantation or punctal plug

• Clinical Parameter: Tear Break Up Time (TBUT)

  Change from Baseline one month after intracanalicular insert implantation or punctal plug

• Clinical Parameter: Conjunctival staining

  Change from Baseline one month after intracanalicular insert implantation or punctal plug

Study Arms (2)

Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)

ACTIVE COMPARATOR

intracanalicular dexamethasone insert

Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)

ProLong™ collagen plugs

PLACEBO COMPARATOR

collagen plug

Other: ProLong™ collagen plugs

Interventions

Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) DRUG

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.

Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)

ProLong™ collagen plugs OTHER

The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.

ProLong™ collagen plugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Pedram Hamrah, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: August 27, 2020
• Study Start: September 4, 2020
• Primary Completion: November 17, 2023
• Study Completion: December 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)