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

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ClinicalTrials.gov Identifier: NCT04527887
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : July 12, 2022
Sponsor:
Collaborator:
Ocular Therapeutix, Inc.
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) Other: ProLong™ collagen plugs Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
intracanalicular dexamethasone insert
 Drug: 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.
Placebo Comparator: ProLong™ collagen plugs
collagen plug
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in ocular inflammation [ Time Frame: 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 :
  1. Clinical Parameter: Ocular Surface Disease Index (OSDI) [ Time Frame: 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

  2. Clinical Parameter: Ocular Pain Assessment Survey (OPAS) [ Time Frame: 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.)

  3. Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE) [ Time Frame: 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.

  4. Clinical Parameter: Tear Break Up Time (TBUT) [ Time Frame: 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.

  5. Clinical Parameter: Conjunctival staining [ Time Frame: 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.

  6. Clinical Parameter: Corneal staining with fluorescein [ Time Frame: 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.

  7. Clinical Parameter: Schirmer II test [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527887


Contacts
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Contact: Nancy Gee, MPH 617-636-5489 ngee@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nancy Gee, MPH    617-636-5489    ngee@tuftsmedicalcenter.org   
Contact: Michael Dixon    617-636-1051    mdixon3@tuftsmedicalcenter.org   
Principal Investigator: Pedram Hamrah, MD         
Sponsors and Collaborators
Tufts Medical Center
Ocular Therapeutix, Inc.
Investigators
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Principal Investigator: Pedram Hamrah, MD Tufts Medical Center
More Information
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04527887    
Other Study ID Numbers: STUDY00000084
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Inflammation
Pathologic Processes
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Dexamethasone
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents