Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
NCT ID: NCT04527887
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
54 participants
INTERVENTIONAL
2020-09-04
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
intracanalicular dexamethasone insert
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.
ProLong™ collagen plugs
collagen plug
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 ocular surgery, corneal infection, or corneal injury within the last 3 months
* Active ocular allergies
* Active ocular infection
* Allergic to benzalkonium chloride
18 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pedram Hamrah, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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STUDY00000084
Identifier Type: -
Identifier Source: org_study_id
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