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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111674 | Other Identifier | Japic |
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The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solution | Experimental | A single dose of OPC-12759 Ophthalmic solution for two-day treatment |
|
| Suspension | Active Comparator | A single dose of OPC-12759 Ophthalmic suspension for two-day treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-12759 Ophthalmic solution | Drug | 2ï¼… OPC-12759 Ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Blurred Vision After Instillation | The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects. | The first and second instillation |
| Number of Subjects With Bitter Taste | The number of subjects with bitter taste on first and/or second instillation was calculated for subjects. | The first and second instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Murakami | Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai region | Osaka | Japan |
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This study was a single-center, randomized, crossover, open-label study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation. The second instillation was conducted within 14 days after the first instillation. |
| FG001 | OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation. The second instillation was conducted within 14 days after the first instillation. |
| FG002 | OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed | One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation. The second instillation was conducted within 14 days after the first instillation. |
| FG003 | OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed | One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation. The second instillation was conducted within 14 days after the first instillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-12759 Solution | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. |
| BG001 | OPC-12759 Suspension | One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Blurred Vision After Instillation | The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects. | Analysis set consisted of all subjects who had received the investigational product at least once. | Posted | Number | participants | The first and second instillation |
|
Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once.
White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation.
Adverse Events detected were systemic and not attributable to one specific intervention or another.
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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-12759 Solution | One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| OPC-12759 Ophthalmic suspension |
| Drug |
2ï¼… OPC-12759 Ophthalmic suspension |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | OPC-12759 Suspension With Nasal Root Pressed/Not Pressed | One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation. The second instillation was conducted within 14 days after the first instillation. |
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| Primary | Number of Subjects With Bitter Taste | The number of subjects with bitter taste on first and/or second instillation was calculated for subjects. | Analysis set consisted of all subjects who had received the investigational product at least once. | Posted | Number | participants | The first and second instillation |
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| 0 |
| 50 |
| 0 |
| 50 |
| 6 |
| 50 |
| EG001 | OPC-12759 Suspension | One drop of OPC-12759 ophthalmic suspension was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation). | 0 | 50 | 0 | 50 | 2 | 50 |
| Herpes zoster | Infections and infestations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.1 | Non-systematic Assessment |
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| Without Nasal Root Press |
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