OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects

NCT ID: NCT05583474

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-27
• Study Completion Date: 2024-12-26

Brief 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.

Detailed Description

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.

Conditions

Open Angle Glaucoma or Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

subject receive OPC-1085EL solution

OPC-1085EL group ，one drop for each eye, once per day for 8 weeks

Group Type: EXPERIMENTAL

OPC-1085EL

Intervention Type: DRUG

one drop for each eye, once per day

subject receive 0.005% latanoprost ophthalmic solution

0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks

Group Type: ACTIVE_COMPARATOR

0.005% Latanoprost

Intervention Type: DRUG

one drop for each eye, once per day

Interventions

OPC-1085EL

one drop for each eye, once per day

Intervention Type: DRUG

0.005% Latanoprost

one drop for each eye, once per day

Intervention Type: DRUG

Other Intervention Names

OPC-1085EL ophthalmic solution; 0.005% Latanoprost ophthalmic solution

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huaixing Sun, Doctor

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital of Fudan University

Locations

Eye & ENT Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

001-403-00013

Identifier Type: -

Identifier Source: org_study_id