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The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.
The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservative-free timolol | Active Comparator |
| |
| Preservative-free FDC and placebo | Experimental |
| |
| Preservative-free tafluprost | Active Comparator |
| |
| Preservative-free FDC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol/ FDC/ Placebo/ Tafluprost | Drug | Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average diurnal IOP | Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months | At 2 and 6 weeks and 6 months |
| Change from baseline in timewise IOPs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Auli Ropo, M.D. | Santen Oy | Study Director |
| Hannu Uusitalo, M.D., Prof. | Tampere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye clinic, University Hospital of Kuopio | Kuopio | 70210 | Finland | |||
| Eye Clinic, University Hospital of Oulu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25447269 | Derived | Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2. |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| C485333 | tafluprost |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)
| At 2 weeks, 6 weeks, 3 months and 6 months |
| Oulu |
| 90029 OYS |
| Finland |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |