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Clinical trials
catalyst calendar across sponsors →Studies where OCUL is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
30 interventional · 3 observational · 13 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| 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 StudyNCT07516132Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144Open-label · Treatment | Phase 3 | Recruiting | Drug: OTX-TKI | Neovascular Age-Related Macular Degeneration (nAMD) | 850 | 2030-08-01 | in 1,441 d | 2026-07-01 |
| A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic RetinopathyNCT07235085DRSS 2-step change status at Week 52 from baseline in the study eye (≥ 2 step improvement, ≥ 2-step worsening, < 2-step change in either direction)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: 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 · Other: Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24 | Non-Proliferative Diabetic Retinopathy | 930 | Mar 2027 | ≤ 222 d | 2026-03-16 |
| Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular DegenerationNCT06495918Best Corrected Visual Acuity (BCVA)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: OTX-TKI, Aflibercept, Aflibercept | Neovascular Age-related Macular Degeneration | 825 | 2027-01-08 | in 140 d | 2025-06-17 |
| Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular DegenerationNCT06223958Best corrected visual acuity (BCVA)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: OTX-TKI (axitinib implant), Aflibercept | Neovascular Age-Related Macular Degeneration | 344 | 2026-04-29 | — | 2025-04-18 |
| OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)NCT05814757Severity of Eye Dryness Score (visual analogue scale (VAS))Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: OTX-DED, Controlled Insertion, Collagen Punctal Plug | Dry Eye Syndromes, Eye Diseases | 100 | 2024-05-22actual | — | 2024-07-10 |
| Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic RetinopathyNCT05695417Safety and TolerabilityRandomized · Triple-masked · Treatment | Phase 1 | Unknown status | Drug: OTX-TKI, Sham | Non-proliferative Diabetic Retinopathy | 21 | Jan 2024 | — | 2023-12-08 |
| 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)NCT05335122Efficacy Outcome: IOP changes from BaselineRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 µg | Open Angle Glaucoma, Ocular Hypertension | 83 | 2024-01-24actual | — | 2025-03-21 |
| CLN-0046: Treatment of AMD Subjects With OTX-TKINCT03630315Incidence of treatment emergent adverse events for each subjectRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: OTX-TKI, OTX-TKI, OTX-TKI, OTX-TKI, Anti-VEGF, OTX-TKI, Anti-VEGF | Neovascular Age-related Macular Degeneration | 29 | 2024-01-10actual | — | 2024-07-10 |
| A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric CataractNCT04539548Adverse EventsRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Dextenza Ophthalmic Insert, Prednisolone acetate ophthalmic suspension USP 1% | Cataract | 65 | 2023-12-21actual | — | 2024-04-15 |
| An Observational, Qualitative Study Assessing Eye Drop AdministrationNCT05307081observationalProportion of patients who meet pre-specified "success" criteria for proper administration of eye drop onto ocular surface on first attempt session as evaluated by the ophthalmologist or optometrist grader | — | Unknown status | Drug: Artificial Tears | Ocular Injury | 300 | Jul 2023 | — | 2022-09-16 |
| Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular DegenerationNCT04989699Safety and TolerabilityRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: OTX-TKI/Sham, Aflibercept/Sham | Neovascular Age-Related Macular Degeneration | 21 | 2023-02-06actual | — | 2024-01-26 |
| A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy SubjectsNCT04945824Ease of insertion as assessed by Post-Insertion Investigator QuestionnaireOpen-label · Other | Early Phase 1 | Terminatedsponsor's stated reason: inserter device did not perform as expected | Drug: Dexamethasone Ophthalmic · Device: Dilator | Healthy | 2 | 2022-11-01actual | — | 2023-02-06 |
| Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.NCT04362670results2023-11-14Number of Subjects With At Least One (1) Treatment Emergent Adverse EventRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: OTX-CSI · Other: Placebo Vehicle | Dry Eye Disease | 153 | 2021-08-11actual | — | 2023-11-14 |
| To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye DiseaseNCT04747977results2023-02-22Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: OTX-DED, OTX-DED, OTX-DED | Dry Eye | 172 | 2021-08-11actual | — | 2023-02-22 |
| CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular HypertensionNCT04360174results2024-10-01Ocular Treatment Emergent Adverse EventsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: OTX-TIC | Ocular Hypertension, Open Angle Glaucoma | 19 | 2021-05-24actual | — | 2024-10-01 |
| OTX-14-002: Device Exposure RegistryNCT02309736observationalOccurrence of endophthalmitis | — | Withdrawnsponsor's stated reason: On going discussions with FDA | Device: ReSure Sealant | Endophthalmitis | 0 | Apr 2020 | — | 2020-02-05 |
| A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic ConjunctivitisNCT04050865results2021-10-07Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Dexamethasone, 0.4mg · Device: Placebo plug with no drug | Allergic Conjunctivitis | 96 | 2020-02-28actual | — | 2021-10-07 |
| A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular InsertNCT04061044Incidence of Treatment-Related Adverse Events (Safety and Tolerability)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Ophthalmic Insert | Open Angle Glaucoma and Ocular Hypertension | 40 | 2020-02-10actual | — | 2023-06-09 |
| Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHTNCT02914509results2021-10-11Mean IOPRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Travoprost · Other: Placebo Vehicle | Open Angle Glaucoma, Ocular Hypertension | 565 | 2019-03-30actual | — | 2021-10-11 |
| Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum PlugNCT01800175Punctum Plug retention for 90 days post insertionNon-randomized · Open-label | Phase 1 | Unknown status | Device: Punctum Plug | Healthy Subjects | 60 | Dec 2016 | — | 2016-02-11 |
| 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 SurgeryNCT02736175results2017-10-11Absence of Anterior Chamber InflammationRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Dexamethasone · Other: Placebo Vehicle | Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation | 438 | May 2016actual | — | 2017-11-13 |
| OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic ConjunctivitisNCT02988882results2018-04-30Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Dexamethasone · Other: Placebo Vehicle | Chronic Allergic Conjunctivitis | 86 | 2016-04-27actual | — | 2020-10-12 |
| ReSure Sealant Post Approval StudyNCT02310815observationalAnterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20) | — | Completed | Device: ReSure Sealant | Adverse Events | 626 | Feb 2016actual | — | 2016-12-05 |
| 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 HypertensionNCT02312544Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 VisitRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: OTX-TP, Timolol | Glaucoma, Ocular Hypertension | 72 | Sep 2015actual | — | 2016-12-14 |
| OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic ConjunctivitisNCT02445326results2018-03-29Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Dexamethasone · Other: Placebo Vehicle | Chronic Allergic Conjunctivitis | 73 | Aug 2015actual | — | 2018-03-29 |
| OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry EyeNCT02468700results2018-03-29Total Corneal Fluorescein StainingRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Dexamethasone · Other: Placebo Vehicle | Dry Eye | 43 | Aug 2015actual | — | 2018-03-29 |
| 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 SurgeryNCT02089113results2016-03-30Number of Participants With an Absence of Anterior Chamber InflammationRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Dexamethasone · Procedure: Placebo Vehicle | Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation | 241 | Jan 2015actual | — | 2019-09-26 |
| Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract SurgeryNCT02034019results2020-01-31Absence of Cells in Anterior Chamber of the Study EyeRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Dexamethasone, Punctum Plug | Post Ocular Surgical Inflammation and Pain | 247 | Dec 2014actual | — | 2020-01-31 |
| OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic ConjunctivitisNCT02062905results2016-05-09Ocular ItchingRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Dexamethasone · Other: Placebo Vehicle | Chronic Allergic Conjunctivitis | 68 | Aug 2014actual | — | 2019-09-11 |
| Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle GlaucomaNCT01845038Mean IOP change from baselineRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: 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 | Glaucoma | 41 | Mar 2014actual | — | 2016-12-12 |
| Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract SurgeryNCT01666210results2017-04-27Absence of Cells in Anterior Chamber of Study EyeRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: OTX-DP (Dexamethasone punctum plug), Placebo Vehicle Punctum Plug | Ocular Inflammation and Pain | 60 | Aug 2013actual | — | 2021-10-19 |
| ReSure Sealant Pivotal StudyNCT01498224Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.Randomized · Single-masked · Treatment | Phase 3 | Completed | Device: ReSure Sealant · Procedure: Sutures | Cataract Surgery Incision Leak | 488 | Nov 2012actual | — | 2016-12-12 |
| I-ZIP Ocular Bandage Pivotal StudyNCT00774228Device remains localized over corneal incisionRandomized · Open-label · Treatment | Not applicable | Completed | Device: I-ZIP Ocular Bandage, Oasis 24 Hour Soft Shield Collagen Corneal Shield | Cataract | 420 | Jul 2009actual | — | 2021-09-29 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19