Treatment-Naïve Patients with Open Angle Glaucoma at High Risk of Glaucomatous Progression. Pacientes Naïve con glaucoma de ángulo abierto con alto riesgo de progresión glaucomatosa.
Conditions
Interventions
Trade Name: GANFORT 300 microgramos/ml+5 mg/ml colirio en solución
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: BIMATOPROST
Other descriptive name: BIMATOPROST
Concentration unit: mg/
Sponsors
Allergan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female Patients aged >18 years and -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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy and safety of bimatoprost/timolol fixed combination vs. latanoprost in patients with elevated intraocular pressure (IOP) and risk factors for glaucoma progression after 3 months of treatment.;Secondary Objective: ? Mean change from Baseline IOP (Day 0) at 8.00, 12.00 and 16.00 hr at 3 months. ? Percentage of patients that reach a predefined target pressure threshold at 3 months. ? Mean of the absolute difference between patient?s highest IOP reading at Baseline (Day 0) and the corresponding IOP reading at 3 months. ? Mean of the absolute difference between patient?s lowest IOP reading at Baseline (Day 0) and the corresponding IOP reading at 3 months. ? Safety assessments.;Primary end point(s): ? Mean change from baseline (Day 0) average IOP (08.00, 12.00 and 16.00 hrs) at 3 months | — |
Countries
Portugal, Spain
Outcome results
None listed