Efficacy and safety of tafluprost 0.0015% eye drops as adjunctive therapy with timolol 0.5% eye drops. A randomised, placebo-controlled, phase III study in patients with open-angle glaucoma or ocular hypertension.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

•Aged 18 years or more
•A diagnosis of open-angle glaucoma (primary open-angle glaucoma, capsular glaucoma or pigmentary glaucoma) or ocular hypertension
•An IOP of 22-30 mmHg at the screening visit with monotherapy other than prostaglandins
•An IOP of 22-30 mmHg in at least one eye in at least one measurement of the diurnal IOP curve (at 8:00, 10:00 and 16:00) at the baseline visit (Visit 2) while having used timolol 0.5% eye drops twice daily as the only glaucoma medication for at least 4 weeks.
•A best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye
•Are willing to follow instructions
•Have provided a written informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
•Previous participation in any clinical trial in which tafluprost was an investigational drug
•Any uncontrolled systemic disease (e.g., hypertension, diabetes)
•Filtration surgery without time limit or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 in the treated eye(s)
•Clinically relevant low or high heart rate or blood pressure for age, or contraindications to beta-blocker therapy such as chronic obstructive pulmonary disease, bronchial asthma, greater than first degree heart block, and uncontrolled congestive heart failure
•Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1, or anticipated change in such therapy during the study
•IOP greater than 30 mmHg at any time point in any eye at Visit 2 (baseline)
•Known allergy or hypersensitivity to the study medications or their components, including benzalkonium chloride (BAK)
•Use of contact lenses at Visit 1 or during the study
•Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from study start
•Any ocular disease/condition that in the opinion of the investigator may put the patient at a significant risk or may confound the study results or may interefere significantly with the patient’s participation in the study
•Any corneal abnormality or other condition preventing reliable applanation tonometry
•Anterior chamber angle less than grade 2 according to Schaffer classification as measured by gonioscopy
•Advanced visual field defect or a visual field defect that is anticipated to progress during the study period
•Use of any other antiglaucoma medications than the study medications during the study
•Current alcohol or drug abuse
•Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials