Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Ocular Hypertension Clinical Trial

Official title:

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 Subjects With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339584
• Other study ID #: C-13-013
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: August 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to intraocular pressure (IOP)-lowering efficacy.

Description:

This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on monotherapy or currently on multiple IOP-lowering medications;

• Mean IOP measurements within guidelines specified in the protocol. Must not be > 36 mmHg at any time point;

• Able to understand and sign an informed consent form;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, test positive for pregnancy, intend to become pregnant during the study period, breast-feeding, or not in agreement to use adequate birth control methods throughout the study;

• Severe central visual field loss in either eye;

• Unable to safely discontinue all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit;

• Chronic, recurrent or severe inflammatory eye disease;

• Ocular trauma within the past 6 months;

• Ocular infection or ocular inflammation within the past 3 months;

• Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;

• Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);

• Other ocular pathology (including severe dry eye) that may preclude the administration of a-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI);

• Intraocular surgery within the past 6 months;

• Ocular laser surgery within the past 3 months;

• Any abnormality preventing reliable applanation tonometry;

• Any conditions including severe illness which would make the Subject, in the opinion of the Investigator, unsuitable for the study;

• History of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would preclude safe administration of a topical a-adrenergic agonist or CAI;

• Recent (within 4 weeks of the E1 Visit) use of high-dose (> 1 g daily) salicylate therapy;

• Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline);

• Concurrent use of monoamine oxidase inhibitors (MAOI);

• Concurrent use of glucocorticoids administered by any route;

• Therapy with another investigational agent within 30 days prior to the Screening Visit;

• Hypersensitivity to a-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications;

• Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding IOP-lowering treatments) 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;

• Use of any additional topical or systemic ocular hypotensive medication during the study;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension

• Brinzolamide 10 mg/mL eye drops, suspension

• Brimonidine 2 mg/mL eye drops, solution

• Vehicle
Inactive ingredients used as a placebo for masking purposes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Diurnal IOP Change From Baseline at Month 3	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.	Baseline (Day 0), Month 3

External Links

•   Results from the Novartis Clinical Trial Results Website