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

Study Overview
=================
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.

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

Conditions
-----------------
Open Angle Glaucoma or Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: OPC-1085EL
* Drug: 0.005% Latanoprost


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subject receive OPC-1085EL solution<br>OPC-1085EL group ，one drop for each eye, once per day for 8 weeks | Drug: OPC-1085EL<br>* one drop for each eye, once per day<br>* Other names: OPC-1085EL ophthalmic solution;|
| Active Comparator: subject receive 0.005% latanoprost ophthalmic solution<br>0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks | Drug: 0.005% Latanoprost<br>* one drop for each eye, once per day<br>* Other names: 0.005% Latanoprost ophthalmic solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure | Week 4；Week 8: | 
| intraocular pressure change from baseline | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure | 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% | 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. | from screening period to evaluation period, assessed up to 3 weeks. |