COMPANY
Santen
FDA-cleared device company Clinical Phase 3
Timeline
- Trial start —: PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group source ↗
- Trial start —: Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life. source ↗
- Trial start 3: LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. source ↗
- Trial start Phase 2: Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia source ↗
- Trial start Phase 2: A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) source ↗
- Trial start Not phased (device or behavioral study): 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis source ↗
- Trial start Not phased (device or behavioral study): 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis source ↗
- Trial start Phase 2: Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or source ↗
- Trial start Phase 3: 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) source ↗
- Trial start III: A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocu source ↗
- Trial start Phase 2: Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6 source ↗
- Trial start III: LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the source ↗
- Trial start Phase 3: DE-117 Spectrum 5 Study source ↗
- Trial start III: A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectru source ↗
- Trial start III: A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectru source ↗
- Trial start II: A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study source ↗
- Trial start Phase 2: Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects source ↗
- Trial start Phase 4: Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis source ↗
- Trial start I: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration source ↗
- Trial start Phase 2: A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration source ↗
- Trial start III: A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posteri source ↗
- Trial start II: Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension source ↗
- Trial start Phase 1: A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension source ↗
- Trial start I: A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration source ↗
- Trial start Phase 2: Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension source ↗
Upcoming milestones
- 2027-09 (ESTIMATED) · · PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group · NCT07235592
Clinical trials (lead sponsor) Showing 50 of 54
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05376176 | A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) | Phase 2 | Completed | May 19, 2022 | May 26, 2025 (actual) |
| NCT07235592 | PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group | Not listed | Recruiting | Mar 19, 2026 | 2027-09 (estimated) |
| NCT06912802 | Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life. | Not listed | Completed | Jul 29, 2025 | Apr 17, 2026 (actual) |
| NCT06514612 | LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. | 3 | Recruiting | Dec 30, 2024 | Aug 1, 2026 (estimated) |
| NCT04685109 | 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis | Not phased (device or behavioral study) | Active, not recruiting | May 11, 2021 | Sep 30, 2026 (estimated) |
| NCT04701086 | 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis | Not phased (device or behavioral study) | Completed | Sep 30, 2021 | Apr 28, 2025 (actual) |
| NCT04144413 | 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) | Phase 3 | Completed | May 31, 2019 | Jul 14, 2023 (actual) |
| NCT05665387 | Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia | Phase 2 | Completed | Dec 22, 2022 | Jul 27, 2023 (actual) |
| NCT04133311 | A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension | III | Completed | Apr 10, 2019 | Feb 3, 2022 (actual) |
| NCT03237936 | Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis | Phase 4 | Completed | Mar 28, 2017 | Jul 11, 2018 (actual) |
| NCT03711929 | LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye | III | Terminated | Nov 19, 2018 | Jun 14, 2022 (actual) |
| NCT03697811 | DE-117 Spectrum 5 Study | Phase 3 | Completed | Sep 27, 2018 | Jan 13, 2022 (actual) |
| NCT03691649 | A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study | III | Completed | Sep 14, 2018 | Dec 6, 2019 (actual) |
| NCT03691662 | A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study | III | Completed | Sep 27, 2018 | Oct 23, 2019 (actual) |
| NCT04742283 | Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension | Phase 2 | Completed | Dec 17, 2020 | Dec 7, 2021 (actual) |
| NCT01751126 | Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis | Phase 3 | Completed | Apr 29, 2013 | 2016-02 (actual) |
| NCT00328653 | Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC) | Phase 2/Phase 3 | Completed | 2006-05 | Feb 22, 2007 (actual) |
| NCT03211234 | Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects | Phase 2 | Completed | Jul 5, 2017 | Dec 31, 2019 (actual) |
| NCT03216902 | A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study | II | Completed | Jul 25, 2017 | Feb 27, 2018 (actual) |
| NCT03858894 | Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6 | Phase 2 | Completed | Jan 28, 2019 | Jun 20, 2019 (actual) |
| NCT02251938 | A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program | III | Completed | Sep 29, 2014 | Nov 1, 2017 (actual) |
| NCT02555306 | A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration | I | Completed | Sep 16, 2015 | 2017-08 (actual) |
| NCT01358266 | Study Assessing Double-masked Uveitis Treatment | Phase 3 | Completed | 2011-05 | 2016-09 (actual) |
| NCT01654484 | A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT | Phase 1/Phase 2 | Completed | 2012-07 | 2012-11 (actual) |
| NCT02022501 | A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration | I | Completed | 2014-01 | Apr 21, 2016 (actual) |
| NCT02401945 | A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration | Phase 2 | Completed | 2015-04 | Jun 22, 2016 (actual) |
| NCT01868126 | Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension | Phase 2 | Completed | 2013-05 | 2013-08 (actual) |
| NCT02179008 | Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension | II | Completed | 2014-06 | 2015-01 (actual) |
| NCT02102750 | A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension | Phase 1 | Completed | 2014-06 | May 29, 2017 (actual) |
| NCT01254370 | Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease | Phase 2 | Completed | 2010-11 | 2011-06 (actual) |
| NCT00739349 | NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye | Phase 2 | Completed | 2008-08 | 2009-01 (actual) |
| NCT00665106 | Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy | Phase 1 | Completed | 2008-04 | 2011-09 (actual) |
| NCT01239069 | Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease | Phase 2 | Completed | 2010-11 | 2011-10 (actual) |
| NCT01087671 | Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops | Phase 3 | Completed | 2010-04 | 2010-10 (actual) |
| NCT01292460 | Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies | Phase 3 | Completed | 2011-02 | 2012-09 (actual) |
| NCT00814944 | A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model | Phase 2 | Completed | 2009-04 | 2009-10 (actual) |
| NCT00766337 | Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration | 2 | Terminated | 2008-12 | 2009-11 (actual) |
| NCT00712491 | Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration | 1 | Terminated | 2008-09 | 2009-11 (actual) |
| NCT00656643 | Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema | Phase 2 | Completed | 2008-06 | 2009-11 (actual) |
| NCT01279083 | Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension | Phase 1/Phase 2 | Completed | 2011-01 | 2011-11 (actual) |
| NCT01468168 | A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients | Phase 2 | Completed | 2011-10 | 2012-11 (actual) |
| NCT01306461 | Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations | Phase 3 | Completed | 2011-03 | 2012-04 (actual) |
| NCT01434888 | Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops | Phase 1 | Completed | 2011-09 | 2011-12 (actual) |
| NCT00868894 | Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension | Phase 1/Phase 2 | Completed | 2009-03 | 2010-05 (actual) |
| NCT00650338 | Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension | Phase 2 | Completed | 2008-03 | 2008-09 (actual) |
| NCT01118754 | Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients | Phase 1/Phase 2 | Completed | 2010-04 | 2010-12 (actual) |
| NCT00918346 | Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation | Phase 3 | Completed | 2005-09 | 2006-03 (actual) |
| NCT00401115 | Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy | Phase 1 | Completed | 2006-09 | 2008-06 (actual) |
| NCT00814515 | Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome | Phase 3 | Completed | 2007-09 | 2009-09 (actual) |
| NCT00879099 | Interaction Study of Timolol Eye Drops and Paroxetine Capsules | Phase 1 | Completed | 2009-04 | 2010-01 (actual) |