Health Condition 1: null- Open Angle Glaucoma or Ocular Hypertension
Conditions
Interventions
Intervention1: brinzolamide 10 mg/mL / brimonidine
2 mg/mL eye drops, suspension: Route of Administration: topical ocular
Duration of Treatment: 6 months
Dosage: 1 drop BID in the treated eye(s)
Contr
Sponsors
Alcon research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult Patients, of either gender, and any race/ethnicity, diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the Investigator are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications. 2. Mean IOP measurements in at least 1 eye, the same eye(s), must be: • >= 24 mmHg and and, • >= 21 mmHg and at both Eligibility 1 and Eligibility 2 Visits, following wash-out of any IOP-lowering medication. Mean IOP must not be > 36 mmHg at any time point. 3. Must be able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Independent Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; are not in agreement to use adequate birth control methods (see the Manual of Procedures) to prevent pregnancy throughout the study. Related to disease/condition being investigated (either eye) 2. Schaffer angle Grade 2 as measured by gonioscopy (extreme narrow angle with complete or partial closure). 3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement). 4. Severe central visual field loss. Severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. 5. Patients who cannot safely undergo the initial wash-out period discontinuing all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit Related to previous or current ocular disease/condition (either eye) 6. Chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis). 7. Ocular trauma within the past 6 months. 8. Ocular infection or ocular inflammation within the past 3 months. 9. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. 10. Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR,20/80 Snellen, or 0.25 decimal). 11. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI). 12. Intraocular surgery within the past 6 months. 13. Ocular laser surgery within the past 3 months. 14. Any abnormality preventing reliable applanation tonometry. Related to current non-ocular disease/condition 15. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study. 16. History of active, severe, unstable or uncontrolled cardiovascular (eg, coronary insufficiency, hypertension, Raynaudâ??s phenomenon, orthostatic hypotension, thromboangiitis obliterans), cerebrovascular (eg, cerebral insufficiency), hepatic, or renal disease that would preclude the safe administration of a topical α-adrenergic agonist or CAI in the opinion of the investigator. Related to previous or concomitant medications 17. Recent (within 4 weeks of the E1 Visit) use of high-dose (1 g daily) salicylate therapy. 18. Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline). 19. Concurrent use of monoamine oxidase inhibitors (MAOI). 20. Concurrent use of glucocorticoids administered by any route. 21. Therapy with another investigational agent within 30 days prior to the Screening Visit. 22. Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator. 23. Less than 30 days stable dosing regimen before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary statistical objective of this non-inferiority study is to demonstrate that the fixed combination (BID) brinzolamide 10 mg/mL / brimonidine 2 mg/mL eyes drops, suspension is non-inferior to the unfixed combination (BID) brinzolamide 10 mg/mL eye drops, suspension plus brimonidine 2 mg/mL eyes drops, solution with respect to IOP-lowering efficacy. Timepoint: At 3rd month | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary endpoints. But there are supportive endpointsTimepoint: 1. diurnal IOP change from baseline (patient IOP change from baseline averaged over the 9 AM and +2 Hrs time points) for Week 2, Week 6, and Month 6 2. mean IOP at Week 2, Week 6, Month 3, and Month 6 for each time point 3. mean IOP change from baseline at Week 2, Week 6, Month 3, and Month 6 for each time point 4. mean IOP percent change from baseline at Week 2, Week 6, Month 3, and Month 6 for each time point. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Colombia, France, Germany, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Spain, Sweden, Taiwan, United Kingdom
Contacts
Public ContactSalman Anzer
Alcon Laboratories
Outcome results
None listed