8 completed, 1 terminated, 1 unknown. 10 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 8, Terminated 1, Unknown 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
Follow Mydriasis: new trials by email Literature Review of Mydriasis trials Research Report on Mydriasis
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 |
|---|---|---|---|---|---|---|
| Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects CTO0303-A, CTO0303-B, CTO0303-C - Pupillary Dilation Effect During Cycloplegic Refraction | Phase 2 / Phase 3 | Unknown | Taejoon Pharmaceutical Co., Ltd. | 156 | 2024-05-09 | 2024-09-24 |
| Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle - Mydriasis, Dilation | Phase 3 | Completed | Opus Genetics, Inc | 23 | 2021-12-17 | 2026-10-30 |
| Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle - Mydriasis, Dilation | Phase 3 | Completed | Opus Genetics, Inc | 368 | 2021-11-18 | 2026-10-30 |
| Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle (Placebo) - Mydriasis, Dilation | Phase 3 | Completed | Opus Genetics, Inc | 185 | 2020-11-18 | 2026-10-30 |
| Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). - Corneal Endothelial Cell Loss, Mydriasis | Phase 3 | Completed | Cairo University | 30 | 2019-02-01 | 2020-05-20 |
| Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation Tropicamide/Phenylephrine ophthalmic solution (TR/PE), Placebo - Mydriasis | Phase 3 | Completed | Eyenovia Inc. | 76 | 2018-12-01 | 2022-03-18 |
| Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Tropicamide 1% ophthalmic solution (TR), Phenylephrine 2.5% ophthalmic solution (PE) - Mydriasis | Phase 3 | Completed | Eyenovia Inc. | 70 | 2018-11-15 | 2022-03-18 |
| Topical 0.4% Ketorolac and Vitreoretinal Surgery Ketorolac - Surgery | Phase 2 / Phase 3 | Completed | Emory University | 76 | 2006-11-01 | 2014-05-14 |
| CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment Mydriasert®, phenylephrine and tropicamide eyedrops - Retinal Anomalies, Premature Birth | Phase 3 | Terminated | Assistance Publique - Hôpitaux de Paris | 80 | 2006-01-01 | 2008-04-10 |
| Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation 1% tropicamide and 10% phenylephrine - Eye Diseases | Phase 3 | Completed | Khon Kaen University | 80 | 2004-12-01 | 2012-03-09 |
Dilatation, Pathologic (3) · Cataract (1) · Corneal Endothelial Cell Loss (1) · Eye Diseases (1) · Premature Birth (1)
Pupil Disorders (10) · Eye Diseases (9) · Pathological Conditions, Signs and Symptoms (4) · Pathological Conditions, Anatomical (3) · Corneal Diseases (1) · Eye Manifestations (1) · Female Urogenital Diseases and Pregnancy Complications (1) · Lens Diseases (1) · Obstetric Labor Complications (1) · Obstetric Labor, Premature (1) · Pathologic Processes (1) · Postoperative Complications (1) · Pregnancy Complications (1) · Signs and Symptoms (1) · Urogenital Diseases (1)
Phenylephrine (3) · Tropicamide (3) · Ketorolac (1) · Ophthalmic Solutions (1)
Opus Genetics, Inc (3) · Eyenovia Inc. (2) · Assistance Publique - Hôpitaux de Paris (1) · Cairo University (1) · Emory University (1) · Khon Kaen University (1) · Taejoon Pharmaceutical Co., Ltd. (1)
United States (6) · Egypt (1) · France (1) · South Korea (1) · Thailand (1)
Tsontcho Ianchulev, MD, MPH (2) · Charles Slonim, MD (1) · Stephen J Kim, MD (1) · Yosanan Yospaiboon, M.D. (1)