OCULAR THERAPEUTIX, INC Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-04-27: Study NCT07516132; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
- 2025-11-17: Study NCT07235085; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
- 2024-11-27: Study NCT06495918; Company role Lead sponsor; Phase Phase 3; Status Active not recruiting.
- 2024-01-29: Study NCT06223958; Company role Lead sponsor; Phase Phase 3; Status Active not recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-04-27 | 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 | Lead sponsor | Phase 3 | Recruiting | Neovascular Age-Related Macular Degeneration (nAMD) | 850 | 2030-08-01 |
| 2025-11-17 | NCT07235085 A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy | Lead sponsor | Phase 3 | Recruiting | Non-Proliferative Diabetic Retinopathy | 930 | 2027-03 |
| 2024-11-27 | NCT06495918 Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration | Lead sponsor | Phase 3 | Active not recruiting | Neovascular Age-related Macular Degeneration | 825 | 2027-01-08 |
| 2024-01-29 | NCT06223958 Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration | Lead sponsor | Phase 3 | Active not recruiting | Neovascular Age-Related Macular Degeneration | 344 | 2027-09-27 |
| 2023-05-11 | NCT05814757 OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) | Lead sponsor | Phase 2 | Completed | Dry Eye Syndromes; Eye Diseases | 100 | 2024-05-22 |
| 2023-01-15 | NCT05695417 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy | Lead sponsor | Phase 1 | Unknown | Non-proliferative Diabetic Retinopathy | 21 | 2024-12 |
| 2022-06-15 | NCT05372315 Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL. | Collaborator Lead: Iworks Laser and Vision Center | Phase 4 | Completed Results posted | Cataract | 80 | 2022-10-31 |
| 2022-04-21 | NCT05307081 An Observational, Qualitative Study Assessing Eye Drop Administration | Lead sponsor | Observational | Unknown | Ocular Injury | 300 | 2023-12 |
| 2022-03-16 | 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) | Lead sponsor | Phase 2 | Completed Results posted | Open Angle Glaucoma; Ocular Hypertension | 83 | 2025-01-24 |
| 2021-12-13 | NCT05143281 The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1 | Collaborator Lead: Grene Vision Group | Phase 4 | Completed | Cataract | 23 | 2023-02-01 |
| 2021-11 | NCT05116345 DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures | Collaborator Lead: Brian Jerkins, MD | Phase 4 | Unknown | Glaucoma Following Surgery | 30 | 2023-11 |
| 2021-09 | NCT04728646 Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes | Collaborator Lead: Massachusetts Eye and Ear Infirmary | Phase 4 | Withdrawn | Graft Vs Host Disease | 0 | 2021-12-13 |
| 2021-08-23 | NCT05023304 In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery | Collaborator Lead: Vance Thompson Vision | Phase 4 | Completed Results posted | Cataract | 30 | 2022-10-01 |
| 2021-07-28 | NCT04989699 Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration | Lead sponsor | Phase 1 | Completed | Neovascular Age-Related Macular Degeneration | 21 | 2023-12-18 |
| 2021-06-01 | NCT04945824 A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects | Lead sponsor | Early Phase 1 | Terminated | Healthy | 2 | 2022-11-01 |
| 2021-04-30 | NCT04708821 DEXTENZA Therapy for Treatment of Allergic Conjunctivitis | Collaborator Lead: Clinical Research Center of Florida | Phase 4 | Completed | Bilateral Conjunctivitis (Disorder) | 31 | 2021-09-02 |
| 2021-04-26 | NCT04863742 Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL | Collaborator Lead: Sight Medical Doctors PLLC | Phase 4 | Unknown | Dry Eye Syndromes | 30 | 2021-09-30 |
| 2021-03 | NCT04529512 INtravitreal and Aqueous Dexamethasone Levels After DEXtenza | Collaborator Lead: Nathan Steinle | Phase 4 | Unknown | Ocular Disease Requiring Surgery | 40 | 2021-03 |
| 2021-02-12 | NCT04747977 To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease | Lead sponsor | Phase 2 | Completed Results posted | Dry Eye | 172 | 2021-09-22 |
| 2021-01 | NCT04530864 Pre-Surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert And Effect On Intraocular Lens Measurement Accuracy | Collaborator Lead: Prism Vision Group | Phase 4 | Unknown | Dry Eye Disease; Cataract Surgery; Ocular Surface Disease | 35 | 2021-07 |
| 2020-12-09 | NCT04563299 Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections | Collaborator Lead: Retina Vitreous Associates of Florida | Phase 4 | Terminated | Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion | 10 | 2023-02-14 |
| 2020-12-01 | NCT04687800 Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery | Collaborator Lead: Cathleen McCabe MD | Phase 4 | Terminated | Cataract | 1 | 2022-10-24 |
| 2020-11 | NCT04563559 PREFERENTIAL Study | Collaborator Lead: Duke University | Phase 2, Phase 3 | Withdrawn | Cataract Surgery; Glaucoma Surgery | 0 | 2021-11 |
| 2020-10-01 | NCT04403516 Dextenza in Pterygium Surgery | Collaborator Lead: Michelle Rhee MD | Phase 4 | Completed | Pterygium | 30 | 2021-08-05 |
| 2020-09-04 | NCT04539548 A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract | Lead sponsor | Phase 3 | Completed | Cataract | 65 | 2023-12-21 |
| 2020-09-04 | NCT04527887 Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) | Collaborator Lead: Tufts Medical Center | Phase 4 | Terminated | Dry Eye | 54 | 2024-12-31 |
| 2020-08-01 | NCT04413279 Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease | Collaborator Lead: Eye Surgeons of Indiana | Phase 4 | Completed | Dry Eye Syndromes | 20 | 2021-07-01 |
| 2020-08-01 | NCT04413253 Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease | Collaborator Lead: Eye Surgeons of Indiana | Phase 4 | Terminated | Dry Eye Syndromes | 5 | 2022-04-11 |
| 2020-07-14 | NCT04464629 Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment | Collaborator Lead: Midwest Eye Institute | Phase 4 | Terminated | Retinal Detachment | 7 | 2023-01-25 |
| 2020-06-08 | NCT04396990 The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study | Collaborator Lead: Vance Thompson Vision | Phase 4 | Completed Results posted | Refractive Surgery | 20 | 2020-09-28 |
| 2020-06-01 | NCT04371445 Dextenza in the Post-op Management of Vitreoretinal Surgeries | Collaborator Lead: The Cleveland Clinic | Phase 4 | Recruiting | Vitreoretinal Surgery; Ocular Inflammation; Post-operative Pain; Post-Operative Inflammation | 30 | 2027-12-01 |
| 2020-04-23 | NCT04362670 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Dry Eye Disease | 153 | 2021-08-11 |
| 2020-02-12 | NCT04168112 Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study | Collaborator Lead: Sight Medical Doctors PLLC | Phase 4 | Completed Results posted | Keratoconus, Unstable; Collagen Crosslinking; Postoperative Pain | 20 | 2023-04-05 |
| 2020-01-13 | NCT04200651 Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery | Collaborator Lead: The New York Eye Surgery Center | Phase 4 | Terminated Results posted | Glaucoma; Cataract | 25 | 2023-07-12 |
| 2020-01-03 | NCT04462523 DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery | Collaborator Lead: Patrick R. Oellers, MD | Phase 4 | Completed | Vitreo-Retinal Surgery | 40 | 2022-03-31 |
| 2019-12-10 | NCT04316936 Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery | Collaborator Lead: Silverstein Eye Centers | Phase 4 | Completed | Cataract Surgery | 15 | 2020-12-23 |
| 2019-11-04 | NCT04205916 A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery | Collaborator Lead: Ophthalmic Consultants of Long Island | Phase 4 | Recruiting | Patient Preference | 50 | 2020-12-01 |
| 2019-08-05 | NCT04050865 A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis | Lead sponsor | Phase 3 | Completed Results posted | Allergic Conjunctivitis | 96 | 2020-02-28 |
| 2019-02-18 | NCT03630315 CLN-0046: Treatment of AMD Subjects With OTX-TKI | Lead sponsor | Phase 1 | Completed | Neovascular Age-related Macular Degeneration | 29 | 2024-01-10 |
| 2018-07-10 | NCT04061044 A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert | Lead sponsor | Phase 3 | Completed | Open Angle Glaucoma and Ocular Hypertension | 40 | 2020-09-22 |
| 2018-04-25 | NCT04360174 CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension | Lead sponsor | Phase 1 | Completed Results posted | Ocular Hypertension; Open Angle Glaucoma | 19 | 2021-05-24 |
| 2016-11-07 | NCT02914509 Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT | Lead sponsor | Phase 3 | Completed Results posted | Open Angle Glaucoma; Ocular Hypertension | 565 | 2019-03-30 |
| 2015-10 | 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 | Lead sponsor | Phase 3 | Completed Results posted | Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation | 438 | 2016-07 |
| 2015-06 | NCT02988882 OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Lead sponsor | Phase 3 | Completed Results posted | Chronic Allergic Conjunctivitis | 86 | 2016-04-27 |
| 2015-04 | NCT02445326 OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Lead sponsor | Phase 3 | Completed Results posted | Chronic Allergic Conjunctivitis | 73 | 2015-09 |
| 2015-01 | NCT02468700 OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye | Lead sponsor | Phase 2 | Completed Results posted | Dry Eye | 43 | 2015-11 |
| 2014-12 | NCT02310815 ReSure Sealant Post Approval Study | Lead sponsor | Observational | Completed | Adverse Events | 626 | 2016-04 |
| 2014-11 | 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 | Lead sponsor | Phase 2 | Completed | Glaucoma; Ocular Hypertension | 72 | 2015-12 |
| 2014-04 | 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 | Lead sponsor | Phase 3 | Completed Results posted | Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation | 241 | 2015-03 |
| 2014-03 | NCT02062905 OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis | Lead sponsor | Phase 2 | Completed Results posted | Chronic Allergic Conjunctivitis | 68 | 2014-11 |
| 2014-02 | NCT02034019 Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | Lead sponsor | Phase 3 | Completed Results posted | Post Ocular Surgical Inflammation and Pain | 247 | 2015-02 |
| 2013-04 | NCT01845038 Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma | Lead sponsor | Phase 1 | Completed | Glaucoma | 41 | 2014-05 |
| 2013-02 | NCT01800175 Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug | Lead sponsor | Phase 1 | Unknown | Healthy Subjects | 60 | |
| 2012-10 | NCT01666210 Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | Lead sponsor | Phase 2 | Completed Results posted | Ocular Inflammation and Pain | 60 | 2013-08 |
| 2011-12 | NCT01498224 ReSure Sealant Pivotal Study | Lead sponsor | Phase 3 | Completed | Cataract Surgery Incision Leak | 488 | 2012-11 |
| 2008-10 | NCT00774228 I-ZIP Ocular Bandage Pivotal Study | Lead sponsor | Not applicable | Completed | Cataract | 420 | 2009-08 |
| NCT02309736 OTX-14-002: Device Exposure Registry | Lead sponsor | Observational | Withdrawn | Endophthalmitis | 0 |
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