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

Phase 3

Completed

• Conditions: Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: 0.005% Latanoprost; Drug: OPC-1085EL

• Registration Number: NCT05583474
• Lead Sponsor: Otsuka Beijing Research Institute

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.

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-17
• Primary Completion: 2024-11-22
• Study Completion: 2024-12-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subject receive 0.005% latanoprost ophthalmic solution	0.005% Latanoprost	0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks
subject receive OPC-1085EL solution	OPC-1085EL	OPC-1085EL group ，one drop for each eye, once per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
evaluate pre-dose intraocular pressure change from baseline to week 8	baseline；week 8	Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured

Secondary Outcome Measures

Name	Time	Method
intraocular pressure change from baseline	Week 4；Week 8	evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
intraocular pressure change rate from baseline	week 4:	intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%
intraocular pressure	Week 4；Week 8:	evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
Safety evaluation variable：adverse event	from screening period to evaluation period, assessed up to 3 weeks.	adverse event start date, end date, seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect.

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China