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Clinical trial

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

ID
Name
001-403-00013
Description
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.
Trial arms
Trial start
2022-09-27
Estimated PCD
2024-03-30
Trial end
2024-04-01
Status
Recruiting
Phase
Early phase I
Treatment
OPC-1085EL
one drop for each eye, once per day
Arms:
subject receive OPC-1085EL solution
Other names:
OPC-1085EL ophthalmic solution
0.005% Latanoprost
one drop for each eye, once per day
Arms:
subject receive 0.005% latanoprost ophthalmic solution
Other names:
0.005% Latanoprost ophthalmic solution
Size
240
Primary endpoint
evaluate pre-dose intraocular pressure change from baseline to week 8
baseline；week 8
Eligibility criteria
Inclusion Criteria: 1. Gender: Unlimited 2. Hospitalization status: Outpatients 3. Age: 20-80 years old 4. Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension. \[At the end of the screening period\] 5. 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: 1. Subjects with a best-corrected visual acuity ≤ 0.2. 2. Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma. 3. Subjects who cannot stop using contact lenses during the trial. 4. Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy. 5. Subjects who are allergic to any ingredients in carteolol or latanoprost.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2024-01-05

1 organization

2 products

1 indication

Organization
Otsuka Beijing Research Institute
Product
OPC-1085EL
Indication
Open-Angle Glaucoma
Product
Latanoprost