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

Tufts University

Status and phase: Terminated; Phase 4

Conditions: Dry Eye

Treatments: Other: ProLong™ collagen plugs; Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04527887

STUDY00000084

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

intracanalicular dexamethasone insert

Treatment:

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

ProLong™ collagen plugs

Placebo Comparator group

Description:

collagen plug

Treatment:

Other: ProLong™ collagen plugs