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)

NCT02339584 | Completed Phase 3 Results

• 1 other identifier: C-13-013
• Study Type: interventional
• Target: 493
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

OAG; OHT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Brinz/Brim

EXPERIMENTAL

Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months

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

Brinz+Brim

ACTIVE COMPARATOR

Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months

Drug: Brinzolamide 10 mg/mL eye drops, suspension; Drug: Brimonidine 2 mg/mL eye drops, solution

Interventions

Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension DRUG

Brinz/Brim

Brinzolamide 10 mg/mL eye drops, suspension DRUG

Also known as: AZOPT™

Brinz+Brim

Brimonidine 2 mg/mL eye drops, solution DRUG

Brinz+Brim

Vehicle DRUG

Inactive ingredients used as a placebo for masking purposes

Brinz/Brim

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 α-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 α-adrenergic agonist or CAI;
• Recent (within 4 weeks of the E1 Visit) use of high-dose (\> 1 g daily) salicylate therapy;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate; Suspensions; Ophthalmic Solutions; Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Pharmaceutical Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Clinical Scientific Associate Director, GCRA, GDD
• Organization: Enter Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Management, Asia

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 15, 2015
• Study Start: April 14, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 2, 2018
• Results First Posted: September 7, 2017

Record last verified: 2017-08