investigation of iop and tolerability of bimatoprost 0.01% and tafluprost unit dose preservative free 15 microgram/ml

Conditions: Ocular Hypertension; Glaucoma

Summary: 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.

Eligibility criteria:
inclusion criteria: * a patient suffering from ocular hypertension, xfg or poag and needs treatment in both eyes * patient is at least 18 years * patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form. exclusion criteria: * unwilling to sign informed consent; * younger than 18 years old; * ocular condition that are of safety concern and that can interfere with the study results; * visual field defects with an md value above -15db on either eye on humphrey (or the equivalent in octopus) and/or threatening fixation * contact lens wearer; * closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy; * ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye; * glaucoma surgery within the past 6 months on either eye; * ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye; * concomitant topical ocular medication that can interfere with study medication on either eye; * known hypersensitivity to any component of the trial drug solutions; * other abnormal condition or symptom preventing the patient from entering the trial, according to the investigator's judgement; * refractive surgery patients at any time; * women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing; * inability to adhere to treatment/visit plan; * have participated in any other interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit. * history of copd, asthma or heart failure