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Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DE-111 ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-111 ophthalmic solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in IOP (Intraocular Pressure) at End of Study | Treatment period: Week 0 (Baseline) and Week 52 (End of Study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen study sites | Osaka | Osaka | Japan |
The run-in period of 4 weeks. Switched to DE-111 ophthalmic solution from Tafluprost ophthalmic solution 0.0015%, Timolol ophthalmic solution 0.5%, or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . Treatment period: 52 weeks .
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| ID | Title | Description |
|---|---|---|
| FG000 | Allocated to Tafluprost | Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) . |
| FG001 | Allocated to Timolol | Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation). |
| FG002 | Allocated to Tafluprost + Timolol | Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The run-in Period |
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| ||||||||||||||||||
| Treatment Period , Switched to DE-111 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-111 | Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . |
| 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 | Change From Baseline in IOP (Intraocular Pressure) at End of Study | Posted | Mean | Standard Deviation | mmHg | Treatment period: Week 0 (Baseline) and Week 52 (End of Study) |
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Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
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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-111 | Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA/J ver.14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharal pigmentation | Eye disorders | MedDRA/J ver.14.1 | 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 |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 6 |
| 136 |
| 68 |
| 136 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Growth of eyelashes | Eye disorders | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA/J ver.14.1 | Systematic Assessment |
|
| Nasopharyngitis | Eye disorders | MedDRA/J ver.14.1 | Systematic Assessment |
|
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