This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
* A prospective, randomized, investigator-masked, crossover comparison; * Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study * Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour). * Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit; * Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit; * After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month * After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening; * After another 3 months they will undergo the final evaluation of IOP levels and of tolerability; * Intermediate safety visits may be scheduled at the discretion of the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
Eye drops solution Topical use Once in the evening 3 months
Eye drops solution Topical use Once in the evening 3 months
Hommer Ophthalmology Institute
Vienna, Austria
RECRUITINGUZ Leuven
Leuven, Vlaams Brabant, Belgium
RECRUITINGSan Paolo Hospital
Milan, Italy
the difference in mean IOP values between the 2 groups
Time frame: 6 months
the difference in IOP values between the groups in change from baseline IOP
Time frame: month 3 and month 6
the difference in mean IOP between the 2 groups
Time frame: month 3
the difference in IOP between the 2 groups at each timepoints
Time frame: month 3 and month 6
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Bietti Foundation
Rome, Italy
NOT_YET_RECRUITINGClinical Research Centre Momorial A. de Rotschild
Geneva, Switzerland
NOT_YET_RECRUITINGGloucestershire Hospitals NHS Foundation Trust
Gloucestershire, United Kingdom
NOT_YET_RECRUITINGWestern Eye Hospital
London, United Kingdom
NOT_YET_RECRUITING