A 3-Month, Multicenter, Investigator masked, Pilot Study to Evaluate the Efficacy and Safety of Bimatoprost/Timolol Fixed Combination vs Latanoprost in treatment Naïve Patients with Open Angle Glaucomaat High Risk of Glaucomatous Progressio

Conditions: Treatment-Naïve Patients with Open Angle Glaucoma at High Risk of Glaucomatous Progression.

Registration Number: EUCTR2009-012799-28-PT

Lead Sponsor: Allergan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Male or Female Patients aged >18 years and < 85 years.
2.Patients suffering from treatment-naïve, primary open-angle glaucoma with a baseline IOP ?27 mmHg and ? 34 mmHg in one or both eyes at any of the assessment timepoints (the eye with the higher IOP will be the study eye or if both eyes are the same pressure, the right eye will be the study eye).
3.Patients with at least one of the following risk factors: pseudoexfoliation (PEX), family history of glaucoma, pigment dispersion, optic disc haemorrhages, visual field mean deviation > -6dB, both eyes with an IOP >27mmHg.
4.Best corrected visual acuity (BCVA) (Snellen equivalent: 20/60 in each eye).
5.Patients who are treatment-naïve to ocular hypotensive medications.
6.Patients willing to participate in the study for the whole duration of the study through to follow-up, who are legally able and who have given informed consent to participate in the study.
7.Patient is able to follow study instructions and likely to complete all required visits.
8.Two reliable visual field tests: one performed within 6 months prior to the Baseline (Day 0) visit and a confirmatory test on Baseline (Day 0) prior to randomisation.
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.History of refractive surgery.
2.History of intraocular surgery performed less than 3 months from Baseline (Day 0).
3.A visual field defect that in the opinion of the physician, medical intervention for the patient is necessary.
4.Contraindication to ?-adrenoceptor antagonist therapy including but not limited to: chronic obstructive pulmonary disease (COPD), bronchial asthma or a history of bronchial asthma, sinus bradycardia, second or third degree atrioventricular block, history of severe myocardial infarction or clinically relevant low or high heart (pulse) rate or blood pressure.
5.Known allergy or sensitivity to the study medication(s) or its components.
6.Current ocular inflammation or infection, or history of ocular inflammation or infection in the past three months. Patients with history of uveitis are to be excluded. (Mild blepharitis is acceptable).
7.Corneal abnormalities, in either eye, that would preclude accurate IOP readings with an applanation tonometer.
8.Any history of ocular trauma, in either eye, in the last six months.
9.Contact lens wearers can be included but contact lenses should be removed prior to administration of study product and with at least a 15-minute wait before reinsertion.
10.Required chronic use of other ocular medications, in either eye, during the study other than the study medications. Occasional use of artificial tear products and topical antihistamines is allowed.
11.Intermittent use of oral, injectable or topical ophthalmic steroids within 21 days prior to the Baseline visit (day 0) or anticipated use during the study.
12.Female patients who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential not using a reliable means of contraception. A female is considered of childbearing potential unless she is post-menopausal or without a uterus and/or both ovaries. (NB: A pregnancy test will be performed at Visit 1 for all females of childbearing potential to confirm the patient is not pregnant prior to randomisation).
13.Current enrolment in any investigational drug or device study, or participation within 30 days of Baseline (Day 0).
14.Patient has a condition or is in a situation which, in the Investigator?s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient?s participation in the study.