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NCT Number: NCT05583474

OPC-1085EL 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.

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Key information

Conditions

Open Angle Glaucoma or Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, China

About this study

The trial includes 2 period:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

OPC-1085EL

Drug

one drop for each eye, once per day

Other names: OPC-1085EL ophthalmic solution

0.005% Latanoprost

Drug

one drop for each eye, once per day

Other names: 0.005% Latanoprost ophthalmic solution

Primary outcomes

  1. evaluate pre-dose intraocular pressure change from baseline to week 8

    Time frame: baseline；week 8

    Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured

Secondary outcomes

  1. intraocular pressure

    Time frame: Week 4；Week 8:

    evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure

  2. intraocular pressure change from baseline

    Time frame: Week 4；Week 8

    evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure

  3. intraocular pressure change rate from baseline

    Time frame: week 4:

    intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%

  4. Safety evaluation variable：adverse event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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