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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-1085EL ophthalmic solution | Experimental | Once daily |
|
| Carteolol long-acting ophthalmic solution | Active Comparator | Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-1085EL ophthalmic solution | Drug |
| ||
| Carteolol long-acting ophthalmic solution |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-1085EL Ophthalmic Solution | Once daily OPC-1085EL ophthalmic solution |
| FG001 | Carteolol Long-acting Ophthalmic Solution | Once daily Carteolol long-acting ophthalmic solution |
| FG002 | Carteolol and Latanoprost Ophthalmic Solution | Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-1085EL Ophthalmic Solution | Once daily OPC-1085EL ophthalmic solution |
| BG001 | Carteolol Long-acting Ophthalmic Solution | Once daily Carteolol long-acting ophthalmic solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, Week 8 Predose |
|
From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-1085EL Ophthalmic Solution | Once daily OPC-1085EL ophthalmic solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Ver. 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deputy General Manager, Headquarters of Clinical Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Drug |
|
| 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 |
| Withdrawal by Subject |
|
| BG002 | Carteolol and Latanoprost Ophthalmic Solution | Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| 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. | Posted | Mean | Standard Error | mmHg | Week 8 Predose |
|
|
|
| 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. | Posted | Mean | Standard Error | mmHg | Week 8 at 2 hours after IMP administration |
|
|
|
| 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. | Posted | Mean | Standard Error | mmHg | Week 8 at 8 hours after IMP administration |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, Week 8 at 2 hours after IMP administration |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, Week 8 at 8 hours after IMP administration |
|
|
|
| 0 |
| 78 |
| 21 |
| 78 |
| EG001 | Carteolol Long-acting Ophthalmic Solution | Once daily Carteolol long-acting ophthalmic solution | 1 | 78 | 3 | 78 |
| EG002 | Carteolol and Latanoprost Ophthalmic Solution | Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution | 0 | 37 | 4 | 37 |
| Conjunctival hyperaemia | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Abnormal sensation in eye | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA Ver. 17.0 | Systematic Assessment |
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