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
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|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) Other: ProLong™ collagen plugs||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
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.
- 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
- 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
- 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.)
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Nancy Gee, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Nancy Gee, MPH 617-636-5489 email@example.com|
|Contact: Michael Dixon 617-636-1051 firstname.lastname@example.org|
|Principal Investigator: Pedram Hamrah, MD|
|Principal Investigator:||Pedram Hamrah, MD||Tufts Medical Center|
|Responsible Party:||Tufts Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 27, 2020 Key Record Dates|
|Last Update Posted:||July 12, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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