Open Angle Glaucoma or Ocular Hypertension Clinical Trial
Official title:
A Phase III, Multi-center, Randomized, Single-blind (to Evaluator), Parallel, and Positive-controlled Clinical Trial Evaluating the Efficacy and Safety of OPC-1085EL Ophthalmic Solution in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.
The trial includes 2 period: 1. Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day. 2. Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01343082 -
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02822729 -
A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study
|
Phase 3 | |
| Completed |
NCT02981446 -
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
|
Phase 3 |