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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105285
• Other study ID #: 1085EL-13-003
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2014
• Last updated: November 24, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• OPC-1085EL ophthalmic solution

• Carteolol long-acting ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No