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Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-114 ophthalmic solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Itching Score by Visit | Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | From baseline to 8-week |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Palpebral Hyperemia Score by Visit | Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | From baseline to 8-week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen study sites | Osaka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-114 Ophthalmic Solution | DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-114 Ophthalmic Solution | DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Ocular Itching Score by Visit | Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | Mean | Standard Error | score | From baseline to 8-week |
|
|
8-week
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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 | DE-114 Ophthalmic Solution | DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J ver14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager of Clinical Development Group | Santen Pharmaceutical Co., Ltd. | +81-6-4802-9341 | clinical@santen.co.jp |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | From baseline to 8-week |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Change in Palpebral Hyperemia Score by Visit | Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | Mean | Standard Error | score | From baseline to 8-week |
|
|
|
| Other Pre-specified | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | Mean | Standard Error | score | From baseline to 8-week |
|
|
|
| 0 |
| 130 |
| 9 |
| 130 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Change in baseline to visit 5 (Day42) |
|
| Change in baseline to visit 6 (Day56) |
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| Change in baseline to visit 5 (Day42) |
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| Change in baseline to visit 6 (Day56) |
|