EUCTR2010-024513-31-DEActive, not recruitingNot Applicable
Efficacy and Safety of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Eye Drops, Suspension Compared to Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinz/Brim BID versus Brinzolamide + Brimonidine BID in OAG or OHT
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Alcon Research, Ltd.
- Enrollment
- 820
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients 18 years of age or older, 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 = 36 mmHg at the 9 AM time point and, • = 21 mmHg and = 36 mmHg at the 11 AM time point at both E1 and E2 Visits. 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.
- •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 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
Exclusion Criteria
- •1. Women pregnant, or intending to become pregnant during the study period; breast-feeding; not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Related to disease/condition being investigated (either eye)
- •2. Schaffer angle Grade < 2 as measured by gonioscopy.
- •3. Cup/disc ratio (C/D) greater than 0.80.
- •4. Severe central visual field loss.
- •5. 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 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 a-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, cerebrovascular, hepatic, or renal disease that would preclude the safe administration of a topical a-adrenergic agonist or CAI in the opinion of the investigator.
- •Related to previous or concomitant medications
- •17. Recent 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 a-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 the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to, ß-adrenergic blocking agents.
- •24. Use of any additional topical or systemic ocular hypotensive medication during the study.
Investigators
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