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DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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 |
|---|---|---|---|
| 1 | Experimental | DE-111 ophthalmic solution |
|
| 2 | Active Comparator | Tafluprost ophthalmic solution 0.0015% |
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| 3 | Active Comparator | Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-111 ophthalmic solution | Drug |
| ||
| Tafluprost ophthalmic solution 0.0015% |
| 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 | Japan |
Switched to following three arms randomly from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily).
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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 | Tafluprost | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% | Drug |
|
| FG002 | Tafluprost Plus Timolol | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects who have instilled the investigational drug at least once. Excluded from analysis in Tafluprost (n=1).
Reason: Protocol Violation
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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 | Tafluprost | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. |
| BG002 | Tafluprost Plus Timolol | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes. |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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) |
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Week 0(Baseline) and Week 4(End of Study)
164 patients were allocated in Tafluprost + Timolol group, but, one patient of this group discontinued without dosing the investigational drug or control drug even once.
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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. | 0 | 161 | 0 | 161 | ||
| EG001 | Tafluprost | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. | 0 | 164 | 0 | 164 | ||
| EG002 | Tafluprost Plus Timolol | Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes. | 0 | 163 | 0 | 163 |
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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 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
| Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -0.7 |
| 0.1 |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less. |