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

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

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.

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma or Ocular Hypertension
• Intervention / Treatment: Drug: OPC-1085EL; Drug: 0.005% Latanoprost

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 Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subject receive OPC-1085EL solution; OPC-1085EL group ，one drop for each eye, once per day for 8 weeks	Drug: OPC-1085EL; one drop for each eye, once per day; Other Names: OPC-1085EL ophthalmic solution
Active Comparator: subject receive 0.005% latanoprost ophthalmic solution; 0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks	Drug: 0.005% Latanoprost; one drop for each eye, once per day; Other Names: 0.005% Latanoprost ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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:
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	Week 4；Week 8

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Investigators: Principal Investigator: Huaixing Sun, Doctor, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): December 26, 2024

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Hypertension; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adrenergic Agents; Antihypertensive Agents; Sympatholytics; Adrenergic beta-Antagonists; Adrenergic Antagonists; Latanoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Carteolol
• Other Study ID Numbers: 001-403-00013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No