Back to resultsIntracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) (DEcIDED)
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)
ProLong™ collagen plugs
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
ProLong™ collagen plugs
Arm Description
intracanalicular dexamethasone insert
collagen plug
Outcomes
Primary Outcome Measures
Change in ocular inflammation
As measured by change to dendritic cell density and ocular redness
Secondary Outcome Measures
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
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.)
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.
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.
Clinical Parameter: Conjunctival staining
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: Corneal staining with fluorescein
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
Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes.
Full Information
NCT ID
NCT04527887
First Posted
February 19, 2020
Last Updated
June 11, 2023
Sponsor
Tufts Medical Center
Collaborators
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04527887
Brief Title
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
Acronym
DEcIDED
Official Title
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Ocular Therapeutix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
Arm Type
Active Comparator
Arm Description
intracanalicular dexamethasone insert
Arm Title
ProLong™ collagen plugs
Arm Type
Placebo Comparator
Arm Description
collagen plug
Intervention Type
Drug
Intervention Name(s)
Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ProLong™ collagen plugs
Intervention Description
The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.
Primary Outcome Measure Information:
Title
Change in ocular inflammation
Description
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 Outcome Measure Information:
Title
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Description
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
Title
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
Description
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
Title
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)
Description
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
Title
Clinical Parameter: Tear Break Up Time (TBUT)
Description
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.
Time Frame
Change from Baseline one month after intracanalicular insert implantation or punctal plug
Title
Clinical Parameter: Conjunctival staining
Description
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.
Time Frame
Change from Baseline one month after intracanalicular insert implantation or punctal plug
Title
Clinical Parameter: Corneal staining with fluorescein
Description
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.
Time Frame
Change from Baseline one month after intracanalicular insert implantation or punctal plug
Title
Clinical Parameter: Schirmer II test
Description
Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes.
Time Frame
Change from Baseline one month after intracanalicular insert implantation or punctal plug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Gee, MPH
Phone
617-636-5489
Email
ngee@tuftsmedicalcenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedram Hamrah, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Gee, MPH
Phone
617-636-5489
Email
ngee@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Michael Dixon
Phone
617-636-1051
Email
mdixon3@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Pedram Hamrah, MD
12. IPD Sharing Statement
Learn more about this trial
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
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