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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subject receive OPC-1085EL solution | Experimental | OPC-1085EL group ,one drop for each eye, once per day for 8 weeks |
|
| subject receive 0.005% latanoprost ophthalmic solution | Active Comparator | 0.005% latanoprost ophthalmic solution group ,one drop for each eye, once per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-1085EL | Drug | one drop for each eye, once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluate pre-dose intraocular pressure change from baseline to week 8 | Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured | baseline;week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure | Week 4;Week 8: |
| intraocular pressure change from baseline | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure |
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Inclusion Criteria:
Gender: Unlimited
Hospitalization status: Outpatients
Age: 20-80 years old
Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension.
[At the end of the screening period]
IOP: After 4 weeks treatment with 0.005% latanoprost, the unilateral eye with a pre-dose IOP from 18 mmHg to <30 mmHg, and IOP <30 mmHg in the contralateral eye.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huaixing Sun, Doctor | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| 0.005% Latanoprost | Drug | one drop for each eye, once per day |
|
|
| Week 4;Week 8 |
| intraocular pressure change rate from baseline | intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100% | week 4: |
| Safety evaluation variable:adverse event | adverse event start date, end date, seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect. | from screening period to evaluation period, assessed up to 3 weeks. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |