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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
San Paolo Hospital
Milan, Italy
RECRUITINGChanges in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
Time frame: Month 3, 6, 9, 12
Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)
Time frame: Months 3, 6, 9 ,12
Changes in density of epithelial cells, Langerhans cells, endothelial cells
Time frame: Month 3, 6, 9 ,12
Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)
Time frame: Month 3, 6, 9, 12
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