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

Phase 4

Terminated

• Conditions: Dry Eye
• Interventions: Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg); Other: ProLong™ collagen plugs

• Registration Number: NCT04527887
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-27
• Study Start: 2020-09-04
• Primary Completion: 2023-11-17
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)	Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)	intracanalicular dexamethasone insert
ProLong™ collagen plugs	ProLong™ collagen plugs	collagen plug

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical Parameter: Ocular Surface Disease Index (OSDI)	Change from Baseline one month after intracanalicular insert implantation or punctal plug	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
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)	Change from Baseline one month after intracanalicular insert implantation or punctal plug	Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root.
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)	Change from Baseline one month after intracanalicular insert implantation or punctal plug	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.)
Clinical Parameter: Conjunctival staining	Change from Baseline one month after intracanalicular insert implantation or punctal plug	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.
Clinical Parameter: Tear Break Up Time (TBUT)	Change from Baseline one month after intracanalicular insert implantation or punctal plug	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.
Clinical Parameter: Corneal staining with fluorescein	Change from Baseline one month after intracanalicular insert implantation or punctal plug	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.
Clinical Parameter: Schirmer II test	Change from Baseline one month after intracanalicular insert implantation or punctal plug	Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States