Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-1085EL ophthalmic solution
Latanoprost ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OPC-1085EL ophthalmic solution
Latanoprost ophthalmic solution
Arm Description
Once daily
Once daily
Outcomes
Primary Outcome Measures
Decrease From Baseline in Intraocular Pressure
Secondary Outcome Measures
Intraocular Pressure at Week 8 Predose
Comparison of each group in intraocular pressure at Week 8 Predose. 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
Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.
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 8 Hours After IMP Administration
Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.
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
Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.
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 8 Hours After IMP Administration
Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.
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.
Full Information
NCT ID
NCT02105272
First Posted
March 27, 2014
Last Updated
November 18, 2015
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02105272
Brief Title
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-1085EL ophthalmic solution
Arm Type
Experimental
Arm Description
Once daily
Arm Title
Latanoprost ophthalmic solution
Arm Type
Active Comparator
Arm Description
Once daily
Intervention Type
Drug
Intervention Name(s)
OPC-1085EL ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution
Primary Outcome Measure Information:
Title
Decrease From Baseline in Intraocular Pressure
Time Frame
Baseline, week 8 predose
Secondary Outcome Measure Information:
Title
Intraocular Pressure at Week 8 Predose
Description
Comparison of each group in intraocular pressure at Week 8 Predose. 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.
Time Frame
Week 8 Predose
Title
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Description
Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.
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.
Time Frame
Week 8 at 2 hours after IMP administration
Title
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Description
Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.
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.
Time Frame
Week 8 at 8 hours after IMP administration
Title
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Description
Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.
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.
Time Frame
Baseline, Week 8 at 2 hours after IMP administration
Title
Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Description
Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.
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.
Time Frame
Baseline, Week 8 at 8 hours after IMP administration
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:
Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
Subjects with ocular conditions as defined by the protocol
Facility Information:
City
Kansai Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
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