28 completed, 5 terminated, 1 active not recruiting, 1 withdrawn. 24 Phase 2, 8 Phase 1, 6 Phase 3, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 24 | Completed 20, Terminated 3, Withdrawn 1 |
| Phase 1 | 8 | Completed 7, Terminated 1 |
| Phase 3 | 6 | Completed 5, Terminated 1 |
| Phase 4 | 3 | Completed 2, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia 0.1% STN1013600 ophthalmic solution, 0.3% STN1013600 ophthalmic solution, Placebo - Presbyopia | Phase 2 | Completed | Santen Inc. | 79 | 2022-12-22 | 2024-05-29 |
| Intravitreal Sirolimus as Therapeutic Approach to Uveitis Intravitreal injection 440mcg, Intravitreal injection of sirolimus 880mcg - Uveitis, Intermediate Uveitis | Phase 2 | Withdrawn | Stanford University | 2022-09-01 | 2023-10-26 | |
| 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) STN1010904 ophthalmic suspension 0.03% BID, STN1010904 ophthalmic suspension 0.1% BID, Placebo (Vehicle) BID - Fuchs Endothelial Corneal Dystrophy | Phase 2 | Completed | Santen Inc. | 86 | 2022-05-19 | 2026-08-07 |
| 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 DE-126 Ophthalmic Solution 0.002% QD, Timolol Maleate Ophthalmic Solution 0.5% BID - Primary Open Angle Glaucoma, Ocular Hypertension | Phase 2 | Completed | Santen Inc. | 323 | 2020-12-17 | 2023-06-22 |
| Imaging Quantification of Inflammation (IQI) Standard of Care Imaging - Uveitis | Active not recruiting | The Cleveland Clinic | 50 | 2019-09-22 | 2026-03-04 | |
| 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 DE-117 Ophthalmic Solution QD, DE-117 Ophthalmic Solution BID - Primary Open-angle Glaucoma and Ocular Hypertension | Phase 2 | Completed | Santen Inc. | 98 | 2019-01-28 | 2020-08-04 |
| 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 DE-109 Intravitreal Injections, Sham Procedure, DE-109 Intravitreal Injections (Open Label) - Non Infectious Uveitis | Phase 3 | Terminated | Santen Inc. | 145 | 2018-11-19 | 2023-12-04 |
| 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 DE-117 Ophthalmic Solution, Timolol Maleate Ophthalmic Solution 0.5% - Glaucoma and Ocular Hypertension | Phase 3 | Completed | Santen Inc. | 417 | 2018-09-27 | 2023-08-09 |
| DE-117 Spectrum 5 Study DE-117 Ophthalmic Solution - Primary Open-angle Glaucoma and Ocular Hypertension | Phase 3 | Completed | Santen Inc. | 107 | 2018-09-27 | 2023-08-30 |
| 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 DE-117 Ophthalmic Solution, Timolol Maleate Ophthalmic Solution 0.5% - Glaucoma and Ocular Hypertension | Phase 3 | Completed | Santen Inc. | 426 | 2018-09-14 | 2023-08-30 |
| A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution, Topical ultra-low dose of DE-126 Ophthalmic Solution, Topical low dose of DE-126 Ophthalmic Solution - Open-angle Glaucoma, Ocular Hypertension | Phase 2 | Completed | Santen Inc. | 241 | 2017-07-25 | 2020-10-23 |
| 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 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis, Lucentis - Age-Related Macular Degeneration | Phase 2 | Completed | Santen Inc. | 76 | 2017-07-05 | 2021-07-13 |
| A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration 0.5 mg of DE-122, 1.0 mg of DE-122, 2.0 mg of DE-122 - Age-Related Macular Degeneration | Phase 1 / Phase 2 | Completed | Santen Inc. | 12 | 2015-09-16 | 2020-01-14 |
| A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration DE-120, Aflibercept - Age-Related Macular Degeneration | Phase 2 | Completed | Santen Inc. | 16 | 2015-04-01 | 2018-04-18 |
| 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 DE-109 440 μg - Non-Infectious Uveitis of the Posterior Segment of the Eye | Phase 3 | Completed | Santen Inc. | 60 | 2014-09-29 | 2020-02-12 |
| 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 DE-117 Low Dose ophthalmic solution, DE-117 Low/Middle Dose ophthalmic solution, DE-117 Middle Dose ophthalmic solution - Open-angle Glaucoma, Ocular Hypertension | Phase 2 | Completed | Santen Inc. | 184 | 2014-06-01 | 2018-04-18 |
| A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration DE-120 - Age-Related Macular Degeneration | Phase 1 / Phase 2 | Completed | Santen Inc. | 10 | 2014-01-01 | 2018-04-18 |
| Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension DE-117 ophthalmic solution, latanoprost ophthalmic solution, Placebo - Open-angle Glaucoma or Ocular Hypertension | Phase 2 | Completed | Santen Inc. | 91 | 2013-05-01 | 2018-04-18 |
| A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT DE-117, 0.0015% tafluprost, DE-117 and 0.0015% tafluprost - Glaucoma and Ocular Hypertension | Phase 1 / Phase 2 | Completed | Santen Inc. | 60 | 2012-07-01 | 2018-04-18 |
| Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy Sirolimus, Lidocaine - Geographic Atrophy | Phase 2 | Terminated | National Eye Institute (NEI) | 52 | 2012-02-01 | 2015-12-10 |
Showing 20 of 35. Sign in to see all of them.
Ocular Hypertension (12) · Glaucoma, Open-Angle (9) · Glaucoma (7) · Macular Degeneration (6) · Dry Eye Syndromes (4) · Uveitis (3) · Choroidal Neovascularization (2) · Cataract (1) · Diabetic Retinopathy (1) · Fuchs' Endothelial Dystrophy (1) · Geographic Atrophy (1) · Panuveitis (1) · Presbyopia (1) · Uveitis, Intermediate (1) · Uveitis, Posterior (1)
Sirolimus (8) · Latanoprost (4) · BID protein, human (2) · Ranibizumab (2) · Contraceptives, Oral (1) · Intravitreal Injections (1) · Lidocaine (1) · Moxifloxacin (1) · Ophthalmic Solutions (1) · aflibercept (1) · carotuximab (1) · tafluprost (1)
United States (35) · India (4) · France (3) · Italy (3) · Argentina (2) · Austria (2) · Japan (2) · Turkey (Türkiye) (2) · Brazil (1) · Chile (1) · Colombia (1) · Germany (1) · Israel (1) · Peru (1) · Philippines (1)
Joel Naor, MD (4) · Abu Abraham, MD (1) · Emily Y Chew, MD (1) · Lanita Scott, MD (1) · Pravin Dugel, M.D. (1) · Quan D Nguyen, MD, MSc (1) · Sunil K Srivastava, MD (1) · Wayne Solley, M.D. (1)
PMID 35167779, PMID 37172782, PMID 37172783, PMID 37853676, PMID 40043909