Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: OPC-1085EL ophthalmic solution
* Drug: Carteolol long-acting ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension Exclusion Criteria: Subjects with ocular conditions as defined by the protocol

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-1085EL ophthalmic solution<br>Once daily | Drug: OPC-1085EL ophthalmic solution<br> <br> |
| Active Comparator: Carteolol long-acting ophthalmic solution<br>Once daily | Drug: Carteolol long-acting ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease From Baseline in Intraocular Pressure at Week 8 Predose | Comparison of each group in change from baseline in intraocular pressure. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. | Baseline, Week 8 Predose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure at Week 8 Predose | Comparison of each group in intraocular pressure at Week 8 Predose. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome. | Week 8 Predose | 
| Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome. | Week 8 at 2 hours after IMP administration | 
| Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome. | Week 8 at 8 hours after IMP administration | 
| Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome. | Baseline, Week 8 at 2 hours after IMP administration | 
| Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome. | Baseline, Week 8 at 8 hours after IMP administration |