A phase 3 study to evaluate the efficacy and safety of Brinzolamide /Brimonidine Fixed dose combination as compared to the Brinzolamide and Brimonidine eye drops dosed individually , twice daily in Glaucoma or Ocular Hypertension patients
- Conditions
- Health Condition 1: null- Open Angle Glaucoma or Ocular Hypertension
- Registration Number
- CTRI/2012/04/002568
- Lead Sponsor
- Alcon research Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 820
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 <= 36 mmHg at the 9 AM time point
and,
• >= 21 mmHg and <= 36 mmHg at the 11 AM time point
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method