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

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: OPC-1085EL ophthalmic solution; Drug: Carteolol long-acting ophthalmic solution

• Registration Number: NCT02105285
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-10-15
• Results First Submitted QC: 2015-10-15
• Status Verified: 2015-11
• Results First Posted: 2015-11-17
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC-1085EL ophthalmic solution	OPC-1085EL ophthalmic solution	Once daily
Carteolol long-acting ophthalmic solution	Carteolol long-acting ophthalmic solution	Once daily

Primary Outcome Measures

Name	Time	Method
Decrease From Baseline in Intraocular Pressure at Week 8 Predose	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	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.
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	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.
Intraocular Pressure at Week 8 Predose	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.
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	Baseline, 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.
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	Baseline, 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.