CLINICAL TRIALS PROFILE FOR DEXTENZA
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505(b)(2) Clinical Trials for DEXTENZA
| 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 | >Sponsor | >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. |
| NCT04200651 ↗ | Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery | Recruiting | The New York Eye Surgery Center | 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. |
| 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. |
| 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 ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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