Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-1085EL ophthalmic solution | Experimental | Once daily |
|
| Carteolol long-acting ophthalmic solution | Active Comparator | Once daily |
|
| Latanoprost 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 |
|---|---|---|
| Cmax of Carteolol | Day 1 and Day 7 | |
| Cmax of Latanoprost Acid | Day 1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Carteolol | Day 1 and Day 7 | |
| Tmax of Latanoprost Acid | Day 1 and Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Region | Japan |
Not provided
Not provided
Not provided
| 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 | Latanoprost Ophthalmic Solution | Once daily Latanoprost ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Cmax of Carteolol | Posted | Mean | Standard Deviation | ng/mL | Day 1 and Day 7 |
|
|
Up to 24 days from date of informed consent
Not provided
Not provided
| 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accommodation disorder | Eye disorders | MedDRA (17.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd | +81-3-6361-7366 |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Latanoprost ophthalmic solution | Drug |
|
| BG002 | Latanoprost Ophthalmic Solution | Once daily Latanoprost ophthalmic solution |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Cmax of Latanoprost Acid | Posted | Mean | Standard Deviation | pg/mL | Day 1 and Day 7 |
|
|
|
| Secondary | Tmax of Carteolol | Posted | Median | Full Range | h | Day 1 and Day 7 |
|
|
|
| Secondary | Tmax of Latanoprost Acid | Posted | Median | Full Range | min | Day 1 and Day 7 |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Carteolol Long-acting Ophthalmic Solution | Once daily Carteolol long-acting ophthalmic solution | 0 | 10 | 4 | 10 |
| EG002 | Latanoprost Ophthalmic Solution | Once daily Latanoprost ophthalmic solution | 0 | 10 | 8 | 10 |
| Conjunctival hyperaemia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided