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

Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583474
• Other study ID #: 001-403-00013
• Status: Recruiting
• Phase: Phase 3
• Start date: September 27, 2022
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Otsuka Beijing Research Institute
• Contact: Xinghuai Sun, PHD
• Phone: 18917761818
• Email: xhsun[@]shmu.edu/cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• OPC-1085EL
one drop for each eye, once per day
• 0.005% Latanoprost
one drop for each eye, once per day

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraocular pressure	evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure	Week 4;Week 8:
Secondary	intraocular pressure change from baseline	evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure	Week 4;Week 8
Secondary	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:
Secondary	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.