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Last Updated: February 28, 2024

CLINICAL TRIALS PROFILE FOR DEXTENZA


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505(b)(2) Clinical Trials for Dextenza

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04237012 ↗ ACCURATE Study for Subjects With Dry Eyes Recruiting The Eye Centers of Racine and Kenosha Phase 4 2019-12-16 To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dextenza

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04168112 ↗ Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study Active, not recruiting Ocular Therapeutix, Inc. Phase 4 2020-02-12 There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
NCT04168112 ↗ Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study Active, not recruiting Sight Medical Doctors PLLC Phase 4 2020-02-12 There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
NCT04200651 ↗ Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery Recruiting Ocular Therapeutix, Inc. Phase 4 2020-01-13 In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dextenza

Condition Name

Condition Name for Dextenza
Intervention Trials
Cataract 7
Dry Eye 4
Dry Eye Syndromes 3
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Condition MeSH

Condition MeSH for Dextenza
Intervention Trials
Cataract 14
Inflammation 13
Keratoconjunctivitis Sicca 8
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Clinical Trial Locations for Dextenza

Trials by Country

Trials by Country for Dextenza
Location Trials
United States 41
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Trials by US State

Trials by US State for Dextenza
Location Trials
New York 6
Florida 5
California 5
Indiana 4
Illinois 3
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Clinical Trial Progress for Dextenza

Clinical Trial Phase

Clinical Trial Phase for Dextenza
Clinical Trial Phase Trials
Phase 4 41
Phase 3 1
Early Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Dextenza
Clinical Trial Phase Trials
Recruiting 24
Not yet recruiting 14
Enrolling by invitation 5
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Clinical Trial Sponsors for Dextenza

Sponsor Name

Sponsor Name for Dextenza
Sponsor Trials
Ocular Therapeutix, Inc. 22
Prism Vision Group 2
Nicole Fram M.D. 2
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Sponsor Type

Sponsor Type for Dextenza
Sponsor Trials
Other 41
Industry 24
U.S. Fed 1
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