A 6-month study to compare the efficacy and safety of a Tafluprost–Timolol preservative-free combination against preservative-free Tafluprost or Timolol given alone in patients with glaucoma or ocular hypertensio

Conditions: Ocular hypertension and POAG, capsular glaucoma and pigmentary glaucoma
MedDRA version: 14.0Level: PTClassification code 10035015Term: Pigmentary glaucomaSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2010-022965-82-EE

Lead Sponsor: Santen Oy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion 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, for which the patient has been regularly using prostaglandin (e.g. Xalatan®, Lumigan®, Travatan®, Taflotan®) or timolol 0.5% (several brand names) monotherapy for at least two weeks before Screening (confirmed in anamnesis).
3.Clinical need for additional IOP lowering medication as judged by the investigator and at the Screening visit evaluation in either treated eye:
oIOP measurement of = 22 mmHg at any time of the day for prior timolol users (stratum 1)
OR
oIOP measurement of = 20 mmHg at any time of the day for prior prostaglandin users (stratum 2)

4.At the End-of-run-in visit after 2-week treatment with preservative-free timolol 0.5% (stratum 1) or with preservative-free tafluprost 0.0015% (stratum 2) in either treated eye:
oIOP measurement of = 22 mmHg at 8:00 for prior timolol users (stratum 1)
OR
oIOP measurement of = 20 mmHg at 8:00 for prior prostaglandin users (stratum 2)

5.At the Baseline visit after a washout period of at least 4 weeks in either eye:
oAn increase of at least 2 mmHg in the average diurnal IOP (measured at 8:00, 10:00, 16:00 and 20:00) as compared to the average diurnal IOP at the End-of-run-in visit

6.A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes (i.e. monocular patients are not eligible)
7.Are willing to follow instructions
8.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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

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 of 35 mmHg or greater at any time point in either eye at Screening or End-of-run-in 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