
Ocular Therapeutix Inc
OCULHealthcare|Biotechnology|USA
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Clinical Trials (58)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT04371445 Dextenza in the Post-op Management of Vitreoretinal Surgeries | Vitreoretinal Surgery, Ocular Inflammation | P4 | Recruiting | 30 | RCT, Single-blind | Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp |
| NCT04205916 A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery | Patient Preference | P4 | Recruiting | 50 | RCT, Open-label | Dexamethasone |
| NCT06495918 Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration | Neovascular Age-related Macular Degeneration | P3 | Active | 825 | RCT, Double-blind | OTX-TKI, Aflibercept, Aflibercept |
| NCT07235085 A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy | Non-Proliferative Diabetic Retinopathy | P3 | Recruiting | 930 | RCT, Double-blind | Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24, Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 |
| NCT06223958 Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration | Neovascular Age-Related Macular Degeneration | P3 | Active | 344 | RCT, Double-blind | OTX-TKI (axitinib implant), Aflibercept |
| NCT07516132 Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study | Neovascular Age-Related Macular Degeneration (nAMD) | P3 | Recruiting | 850 | Open-label | OTX-TKI |
| NCT04396990 The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study | Refractive Surgery | P4 | Completed | 20 | RCT, Double-blind | Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone |
| NCT05143281 The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1 | Cataract | P4 | Completed | 23 | RCT, Open-label | Dexamethasone 0.4 MG [Dextenza] |
| NCT04200651 Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery | Glaucoma, Cataract | P4 | Terminated | 25 | RCT, Open-label | Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp |
| NCT04403516 Dextenza in Pterygium Surgery | Pterygium | P4 | Completed | 30 | Open-label | Dexamethasone Intracanalicular Insert, 0.4mg, Prednisolone Acetate 1% |
| NCT04527887 Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) | Dry Eye | P4 | Terminated | 54 | RCT, Double-blind | Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) |
| NCT04563299 Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections | Neovascular Age-related Macular Degeneration, Diabetic Macular Edema | P4 | Terminated | 10 | RCT, Double-blind | Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate |
| NCT04168112 Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study | Keratoconus, Unstable, Collagen Crosslinking | P4 | Completed | 20 | RCT, Open-label | Dextenza, Prednisolone Acetate |
| NCT05372315 Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL. | Cataract | P4 | Completed | 80 | RCT, Open-label | Dextenza 0.4Mg Ophthalmic Insert |
| NCT04464629 Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment | Retinal Detachment | P4 | Terminated | 7 | RCT, Open-label | Dextenza, Prednisolone Acetate |
| NCT04728646 Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes | Graft Vs Host Disease | P4 | Withdrawn | — | RCT, Single-blind | DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use |
| NCT04863742 Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL | Dry Eye Syndromes | P4 | Unknown | 30 | RCT, Open-label | Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate |
| NCT04708821 DEXTENZA Therapy for Treatment of Allergic Conjunctivitis | Bilateral Conjunctivitis (Disorder) | P4 | Completed | 31 | RCT, Open-label | Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension, olopatadine hydrochloride ophthalmic solution 0.7% |
| NCT05116345 DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures | Glaucoma Following Surgery | P4 | Unknown | 30 | RCT, Open-label | DEXTENZA, Topical Dexamethasone |
| NCT04687800 Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery | Cataract | P4 | Terminated | 1 | RCT, Open-label | Dextenza 0.4mg intracanalicular Insert, Durezol 0.05% Ophthalmic Emulsion |
| NCT05023304 In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery | Cataract | P4 | Completed | 30 | RCT, Double-blind | Dextenza 0.4Mg Ophthalmic Insert, Topical prednisolone acetate |
| NCT04413279 Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease | Dry Eye Syndromes | P4 | Completed | 20 | Single-blind | Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation |
| NCT04316936 Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery | Cataract Surgery | P4 | Completed | 15 | RCT, Open-label | Omidria, Dextenza (dexamethasone ophthalmic insert) 0.4mg, Dexycu, 9% Intraocular Suspension, Prednisolone Acetate 1% |
| NCT04529512 INtravitreal and Aqueous Dexamethasone Levels After DEXtenza | Ocular Disease Requiring Surgery | P4 | Unknown | 40 | RCT, Open-label | DEXTENZA® |
| NCT04530864 Pre-Surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert And Effect On Intraocular Lens Measurement Accuracy | Dry Eye Disease, Cataract Surgery | P4 | Unknown | 35 | Open-label | Dextenza 0.4Mg Ophthalmic Insert |
| NCT04413253 Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease | Dry Eye Syndromes | P4 | Terminated | 5 | Single-blind | Lifitegrast 5% Ophthalmic Solution, Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution |
| NCT04462523 DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery | Vitreo-Retinal Surgery | P4 | Completed | 40 | RCT, Single-blind | Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone |
| NCT04426734 Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids | Non-infectious Anterior Uveitis | P4 | Unknown | 30 | RCT, Open-label | Topical Prednisolone Acetate 1% |
| NCT02034019 Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | Post Ocular Surgical Inflammation and Pain | P3 | Completed | 247 | RCT, Double-blind | Dexamethasone, Punctum Plug |
| NCT04539548 A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract | Cataract | P3 | Completed | 65 | RCT, Open-label | Dextenza Ophthalmic Insert, Prednisolone acetate ophthalmic suspension USP 1% |
| NCT04061044 A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert | Open Angle Glaucoma and Ocular Hypertension | P3 | Completed | 40 | Open-label | Ophthalmic Insert |
| NCT02914509 Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT | Open Angle Glaucoma, Ocular Hypertension | P3 | Completed | 565 | RCT, Double-blind | Travoprost |
| NCT02089113 OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery | Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation | P3 | Completed | 241 | RCT, Double-blind | Dexamethasone |
| NCT01498224 ReSure Sealant Pivotal Study | Cataract Surgery Incision Leak | P3 | Completed | 488 | RCT, Single-blind | — |
| NCT02736175 OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery | Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation | P3 | Completed | 438 | RCT, Double-blind | Dexamethasone |
| NCT02988882 OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Chronic Allergic Conjunctivitis | P3 | Completed | 86 | RCT, Double-blind | Dexamethasone |
| NCT04050865 A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis | Allergic Conjunctivitis | P3 | Completed | 96 | RCT, Double-blind | Dexamethasone, 0.4mg |
| NCT04563559 PREFERENTIAL Study | Cataract Surgery, Glaucoma Surgery | P2P3 | Withdrawn | — | Open-label | Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] |
| NCT02445326 OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Chronic Allergic Conjunctivitis | P3 | Completed | 73 | RCT, Double-blind | Dexamethasone |
| NCT05814757 OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) | Dry Eye Syndromes, Eye Diseases | P2 | Completed | 100 | RCT, Double-blind | OTX-DED, Controlled Insertion, Collagen Punctal Plug |
| NCT02468700 OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye | Dry Eye | P2 | Completed | 43 | RCT, Double-blind | Dexamethasone |
| NCT02312544 Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension | Glaucoma, Ocular Hypertension | P2 | Completed | 72 | RCT, Double-blind | OTX-TP, Timolol |
| NCT04362670 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. | Dry Eye Disease | P1P2 | Completed | 153 | RCT, Double-blind | OTX-CSI |
| NCT04747977 To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease | Dry Eye | P2 | Completed | 172 | RCT, Double-blind | OTX-DED, OTX-DED, OTX-DED |
| NCT05335122 A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) | Open Angle Glaucoma, Ocular Hypertension | P2 | Completed | 83 | RCT, Double-blind | OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 µg |
| NCT01666210 Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | Ocular Inflammation and Pain | P2 | Completed | 60 | RCT, Double-blind | OTX-DP (Dexamethasone punctum plug), Placebo Vehicle Punctum Plug |
| NCT02062905 OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Chronic Allergic Conjunctivitis | P2 | Completed | 68 | RCT, Double-blind | Dexamethasone |
| NCT04360174 CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension | Ocular Hypertension, Open Angle Glaucoma | P1 | Completed | 19 | Open-label | OTX-TIC |
| NCT04989699 Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration | Neovascular Age-Related Macular Degeneration | P1 | Completed | 21 | RCT, Double-blind | OTX-TKI/Sham, Aflibercept/Sham |
| NCT01845038 Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma | Glaucoma | P1 | Completed | 41 | RCT, Double-blind | OTX-TPa ~4µg/day over 2 mos. with natural tears drops, OTX-TPb ~3µg/day over 3 months with natural tears drops, Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug |
| NCT03630315 CLN-0046: Treatment of AMD Subjects With OTX-TKI | Neovascular Age-related Macular Degeneration | P1 | Completed | 29 | RCT, Open-label | OTX-TKI, OTX-TKI, OTX-TKI, OTX-TKI, Anti-VEGF, OTX-TKI, Anti-VEGF |
| NCT01800175 Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug | Healthy Subjects | P1 | Unknown | 60 | Open-label | — |
| NCT05695417 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy | Non-proliferative Diabetic Retinopathy | P1 | Unknown | 21 | RCT, Double-blind | OTX-TKI, Sham |
| NCT04945824 A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects | Healthy | Early P1 | Terminated | 2 | Open-label | Dexamethasone Ophthalmic |
| NCT00774228 I-ZIP Ocular Bandage Pivotal Study | Cataract | N/A | Completed | 420 | RCT, Open-label | — |
| NCT05307081 An Observational, Qualitative Study Assessing Eye Drop Administration | Ocular Injury | Unknown | 300 | — | Artificial Tears | |
| NCT02310815 ReSure Sealant Post Approval Study | Adverse Events | Completed | 626 | — | — | |
| NCT02309736 OTX-14-002: Device Exposure Registry | Endophthalmitis | Withdrawn | — | — | — |