- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105285
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Kansai Region, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OPC-1085EL ophthalmic solution
Once daily
|
|
Active Comparator: Carteolol long-acting ophthalmic solution
Once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease From Baseline in Intraocular Pressure at Week 8 Predose
Time Frame: 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.
|
Baseline, Week 8 Predose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure at Week 8 Predose
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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. |
Baseline, Week 8 at 2 hours after IMP administration
|
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Time Frame: 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. |
Baseline, Week 8 at 8 hours after IMP administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Carteolol
Other Study ID Numbers
- 1085EL-13-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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