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

NCT05583474 | Completed Phase 3

• 1 other identifier: 001-403-00013
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• intraocular pressure

  Week 4；Week 8:

• intraocular pressure change from baseline

  Week 4；Week 8

• intraocular pressure change rate from baseline

  week 4:

• Safety evaluation variable：adverse event

  from screening period to evaluation period, assessed up to 3 weeks.

Study Arms (2)

subject receive OPC-1085EL solution

EXPERIMENTAL

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

Drug: OPC-1085EL

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

Drug: 0.005% Latanoprost

Interventions

OPC-1085EL DRUG

one drop for each eye, once per day

Also known as: OPC-1085EL ophthalmic solution

subject receive OPC-1085EL solution

0.005% Latanoprost DRUG

one drop for each eye, once per day

Also known as: 0.005% Latanoprost ophthalmic solution

subject receive 0.005% latanoprost ophthalmic solution

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with a best-corrected visual acuity ≤ 0.2.
• Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
• Subjects who cannot stop using contact lenses during the trial.
• Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
• Subjects who are allergic to any ingredients in carteolol or latanoprost.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Huaixing Sun, Doctor

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 17, 2022
• Study Start: September 27, 2022
• Primary Completion: November 22, 2024
• Study Completion: December 26, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)