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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost/Timolol therapy | Active Comparator | 24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops |
|
| Travoprost therapy | Active Comparator | 24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost/timolol fixed combination, travoprost | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour IOP | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction from baseline | 3 months | |
| Mean fluctuation of 24-hour IOP | 3 months | |
| Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anastasios GP Konstas, MD, PhD | Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaucoma Unit, 1st University Department of Ophthalmology | Thessaloniki | 546 36 | Greece |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| 3 months |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |