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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece
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
Time frame: 3 months
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.
Time frame: 3 months
ocular surface indicators after 3 months of therapy with the two medications
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.
Time frame: 3 months
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