A phase III, randomized, double-masked 6-month clinical study to compare the efficacy and safety of the preservative-free fixed dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given concomitantly in patients with open angle glaucoma or ocular hypertension - Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study against Concomitant Administratio

Conditions: Patients diagnosed with ocular hypertension or open-angle glaucoma (primary open-angle glaucoma [POAG], capsular glaucoma or pigmentary glaucoma).
MedDRA version: 12.1Level: LLTClassification code 10030043Term: Ocular hypertension
MedDRA version: 12.1Level: LLTClassification code 10036719Term: Primary open angle glaucoma
MedDRA version: 12.1Level: LLTClassification code 10035015Term: Pigmentary glaucoma
MedDRA version: 12.1Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucoma

Registration Number: EUCTR2010-022984-36-PT

Lead Sponsor: Santen Oy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

Patients of any race and either sex meeting all of the following criteria:
1.Aged 18 years or more
2.A diagnosis of ocular hypertension or open-angle glaucoma (either POAG, capsular glaucoma or pigmentary glaucoma) in one or both eyes
3.Clinical need for additional IOP lowering medication as judged by the investigator and an untreated (after washout if applicable) IOP of =23 mmHg at the 8:00 measurement at baseline in one or both eyes
4.Patients on prior glaucoma medication must have following minimum washout:
•=4 weeks for ß-adrenergic antagonists (ß-blockers)
•=4 weeks for prostamides or prostaglandin analogues
•=3 weeks for a-adrenergic agonists (a-agonists)
•=7 days for carbonic anhydrase inhibitors (CAIs)
•=5 days for miotics
5.A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes (i.e. monocular patients are not eligible)
6.Are willing to follow instructions
7.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

1.Females who are pregnant, nursing or planning pregnancy, or females of childbearing potential who are not using a reliable method of contraception
2.Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
3.Any corneal abnormality or other condition preventing reliable applanation tonometry in the treated eyes, including prior refractive eye surgery
4.IOP greater than 36 mmHg at any time point in either eye at Screening or Baseline visits
5.Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
6.Suspected contraindication to tafluprost or timolol therapy;
a.hypersensitivity to tafluprost/timolol or any of the excipients
b.low heart rate of <50 bpm (at Screening visit) or clinically relevant low blood pressure for age, chronic obstructive pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias, the most common of which are second or third degree AV block and bradycardia, or uncontrolled congestive heart failure
c.also for washout medication Azopt® (use of which is judged by the investigator): hypersensitivity to brinzolamide or any of the excipients, known hypersensitivity to sulphonamide, severe renal insufficiency or hyperchloraemic acidosis
7.Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication
8.Use of contact lenses at Screening or during the study
9.Advanced visual field defect in either eye or anticipated progression during the study as judged by the investigator
10.Inability to safely discontinue the use of ocular hypotensive medications during the washout period
11.Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses, known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g. uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator
12.Change of an existing chronic therapy that could substantially affect the IOP or the study outcomes within 30 days prior to Visit 1, or anticipated change in such therapy during the study
13.Current alcohol or drug abuse
14.Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days