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

Primary Purpose

Open Angle Glaucoma or Ocular Hypertension

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
OPC-1085EL
0.005% Latanoprost
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma or Ocular Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye & ENT Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

subject receive OPC-1085EL solution

subject receive 0.005% latanoprost ophthalmic solution

Arm Description

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

0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

intraocular pressure
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
intraocular pressure change from baseline
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
intraocular pressure change rate from baseline
intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%
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.

Full Information

First Posted
October 8, 2022
Last Updated
October 7, 2023
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05583474
Brief Title
OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma or Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subject receive OPC-1085EL solution
Arm Type
Experimental
Arm Description
OPC-1085EL group ，one drop for each eye, once per day for 8 weeks
Arm Title
subject receive 0.005% latanoprost ophthalmic solution
Arm Type
Active Comparator
Arm Description
0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-1085EL
Other Intervention Name(s)
OPC-1085EL ophthalmic solution
Intervention Description
one drop for each eye, once per day
Intervention Type
Drug
Intervention Name(s)
0.005% Latanoprost
Other Intervention Name(s)
0.005% Latanoprost ophthalmic solution
Intervention Description
one drop for each eye, once per day
Primary Outcome Measure Information:
Title
evaluate pre-dose intraocular pressure change from baseline to week 8
Description
Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured
Time Frame
baseline；week 8
Secondary Outcome Measure Information:
Title
intraocular pressure
Description
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
Time Frame
Week 4；Week 8:
Title
intraocular pressure change from baseline
Description
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
Time Frame
Week 4；Week 8
Title
intraocular pressure change rate from baseline
Description
intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%
Time Frame
week 4:
Title
Safety evaluation variable：adverse event
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghuai Sun, PHD
Phone
18917761818
Email
xhsun@shmu.edu/cn
First Name & Middle Initial & Last Name or Official Title & Degree
Kaidi Wang, PHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huaixing Sun, Doctor
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaixing Sun, PHD
Phone
18917761818
Email
xhsun@shmu.edu/cn

12. IPD Sharing Statement

Learn more about this trial

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

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