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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001778-24 | EudraCT Number |
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The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafluprost 0.0015% | Active Comparator |
| |
| Timolol 0.5% | Active Comparator |
| |
| Fixed-dose combination of tafluprost 0.0015% and timolol 0.5% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative free tafluprost 0.0015% eye drops | Drug | Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops. | The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol. | There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops. | The changes from screening/baseline will be evaluated in following variables:visual acuity, IOP, biomicroscopy and ophthalmoscopy findings and drop discomfort. Adverse events will be followed from screening to post-study visit. | Day 1 and Day 7 of treatment periods I, II and III. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital Eye Clinic | Kuopio | 70200 | Finland |
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| Preservative free timolol 0.5% eye drops | Drug | Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days |
|
| Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops | Drug | Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00. |
|
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
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