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DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-111 ophthalmic solution | Experimental | DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
|
| Timolol ophthalmic solution 0.5% | Active Comparator | Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-111 ophthalmic solution | Drug |
| ||
| Timolol ophthalmic solution 0.5% |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study | Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30. | Week 0(Baseline) and Week 4(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 |
Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-111 | DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
| FG001 | Timolol | Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who have instilled the investigational drug at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-111 | DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
| BG001 | Timolol | Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. |
| 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 Mean Diurnal IOP (Intraocular Pressure) at End of Study | Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30. | Posted | Mean | Standard Deviation | mmHg | Week 0(Baseline) and Week 4(End of Study) |
|
Week 0(Baseline) and Week 4(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 | DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | 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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| Drug |
|
| Placebo ophthalmic solution | Drug |
|
| Withdrawal by Subject |
|
| BG002 | 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 82 |
| 11 |
| 82 |
| EG001 | Timolol | Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. | 0 | 84 | 2 | 84 |
| Conjunctival hyperaemia | Eye disorders | MedDRA/J ver.14.1 | Systematic Assessment |
|
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