Last updated on February 2018

Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml

Brief description of study

This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.

Detailed Study Description

  • 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.

Clinical Study Identifier: NCT02471105

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Anton Hommer

Hommer Ophthalmology Institute
Vienna, Austria
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