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

Phase 4TerminatedNCT04527887

Tufts Medical Center54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye

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.

ProLong™ collagen plugsOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in ocular inflammation

As measured by change to dendritic cell density and ocular redness

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

Secondary Outcomes

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

Time frame: 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.)

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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