Intraocular pressure and tolerability Study of Preserved Bimatoprost 0.1% (BMD) or Tafluprost Unit Dose Preservative Free 15microgram/ml (TUDPF) (Saflutan), in patients with Ocular hypertension or glaucoma suitable for prostaglandin therapy: A Randomized, single masked, 3 month cross-over, Investigator led, European multicentre Trial, II (SPORT II) - SPORTII

Z Leuven0 个研究点目标入组 67 人开始时间: 2014年11月12日最近更新: 2021年3月8日

试验速览

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•A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes
•At screening visit (09:00 ± 1 hr) the IOP is less than or equal to 21 mm Hg in both eyes.
•Patient is older than 39 years and younger than 85 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

•Unwilling to sign informed consent;
•Not at least 40 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
•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.

发起方

Z Leuven