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The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost/Timolol therapy | Active Comparator | Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy |
|
| Latanoprost/Timolol therapy | Active Comparator | Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost/timolol therapy | Drug | Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour intraocular pressure reduction between the two medications | Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of adverse events with the two medications | At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health. | 3 months |
| ocular surface indicators after 3 months of therapy with the two medications |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
| D000077338 | Latanoprost |
| C571753 | Xalacom |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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|
| Latanoprost/Timolol therapy | Drug | Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy |
|
|
Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications. |
| 3 months |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |