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A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.
At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafluprost | Active Comparator | 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) |
|
| Latanoprost | Active Comparator | 1 drop of latanoprost to eligible eye(s) once daily (at 9 pm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafluprost | Drug | 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants | Month 3, 6, 9, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity) | Months 3, 6, 9 ,12 | |
| Changes in density of epithelial cells, Langerhans cells, endothelial cells | Month 3, 6, 9 ,12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Rossetti, MD | Contact | +390281844401 | luca.rossetti@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Rossetti, MD | San Paolo Hospital, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Paolo Hospital | Recruiting | Milan | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25893514 | Derived | Fogagnolo P, Dipinto A, Vanzulli E, Maggiolo E, De Cilla' S, Autelitano A, Rossetti L. A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients. Adv Ther. 2015 Apr;32(4):356-69. doi: 10.1007/s12325-015-0205-5. Epub 2015 Apr 19. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Latanoprost |
| Drug |
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) |
|
| Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test) | Month 3, 6, 9, 12 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |