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
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- STATUS
- Recruiting
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- End date
- Apr 21, 2024
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- participants needed
- 240
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- sponsor
- Otsuka Beijing Research Institute
Summary
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.
Description
The trial includes 2 period:
- 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.
- 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.
Details
| Condition | Open Angle Glaucoma or Ocular Hypertension |
|---|---|
| Treatment | OPC-1085EL, 0.005% Latanoprost |
| Clinical Study Identifier | NCT05583474 |
| Sponsor | Otsuka Beijing Research Institute |
| Last Modified on | 21 October 2022 |
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