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

Otsuka Beijing Research Institute204 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

204

Conditions

Open Angle Glaucoma or Ocular Hypertension

Interventions

OPC-1085ELDRUG

one drop for each eye, once per day

0.005% LatanoprostDRUG

one drop for each eye, once per day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: baseline；week 8

Secondary Outcomes

intraocular pressure

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

Time frame: Week 4；Week 8:

intraocular pressure change from baseline

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

Time frame: Week 4；Week 8

intraocular pressure change rate from baseline

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

Time frame: week 4:

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.

Time frame: from screening period to evaluation period, assessed up to 3 weeks.

Data from ClinicalTrials.gov

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