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Last Updated: May 16, 2021

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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 Not yet recruiting Ocular Therapeutix, Inc. Phase 4 2020-01-01 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 Not yet recruiting Sight Medical Doctors PLLC Phase 4 2020-01-01 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 Not yet recruiting Ocular Therapeutix, Inc. Phase 4 2020-01-02 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.
NCT04200651 Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery Not yet recruiting The New York Eye Surgery Center Phase 4 2020-01-02 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.
NCT04205916 A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery Recruiting Ocular Therapeutix, Inc. Phase 4 2019-11-04 To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
NCT04205916 A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery Recruiting Ophthalmic Consultants of Long Island Phase 4 2019-11-04 To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dextenza

Condition Name

Condition Name for Dextenza
Intervention Trials
Cataract 4
Dry Eye 3
Dry Eye Syndromes 3
Patient Preference 2
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Condition MeSH

Condition MeSH for Dextenza
Intervention Trials
Inflammation 11
Cataract 9
Keratoconjunctivitis Sicca 7
Dry Eye Syndromes 7
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Clinical Trial Locations for Dextenza

Trials by Country

Trials by Country for Dextenza
Location Trials
United States 20
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Trials by US State

Trials by US State for Dextenza
Location Trials
New York 4
Florida 3
Ohio 3
California 2
Montana 1
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Clinical Trial Progress for Dextenza

Clinical Trial Phase

Clinical Trial Phase for Dextenza
Clinical Trial Phase Trials
Phase 4 32
Phase 3 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Dextenza
Clinical Trial Phase Trials
Not yet recruiting 23
Recruiting 11
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Clinical Trial Sponsors for Dextenza

Sponsor Name

Sponsor Name for Dextenza
Sponsor Trials
Ocular Therapeutix, Inc. 18
Prism Vision Group 2
Vance Thompson Vision 2
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Sponsor Type

Sponsor Type for Dextenza
Sponsor Trials
Other 33
Industry 19
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