Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension

NCT01357616 | Completed Phase 3 Results

• 1 other identifier: C-08-076
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution, each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Open-angle glaucoma; Ocular hypertension; OAG; OH

Outcome Measures

Primary Outcomes (1)

• Mean Diurnal IOP Change From Baseline at Week 8

  Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..

  Baseline, Week 8

Secondary Outcomes (3)

• Mean IOP Change From Baseline at 9 AM

  Baseline, Up to Week 8

• Mean IOP Change From Baseline at 11 AM

  Baseline, Up to Week 8

• Mean IOP Change From Baseline (5 PM) at Week 8

  Baseline, Week 8

Study Arms (2)

AZARGA

EXPERIMENTAL

Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.

Drug: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension

AZOPT + Timolol

ACTIVE COMPARATOR

Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.

Drug: Brinzolamide 1% ophthalmic suspension; Drug: Timolol 0.5% ophthalmic solution

Interventions

Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension DRUG

Also known as: AZARGA™

AZARGA

Brinzolamide 1% ophthalmic suspension DRUG

Also known as: AZOPT®

AZOPT + Timolol

Timolol 0.5% ophthalmic solution DRUG

Also known as: TIMOLOL

AZOPT + Timolol

Eligibility Criteria

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

You may qualify if:

• Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy.
• Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit.
• Willing to sign an Informed Consent form.
• Contact lens wearer who is willing to remove lenses before instillation of study medication and wait a minimum of 15 minutes following drug instillation before re-inserting the lenses.
• Able to discontinue use of current IOP-lowering medications per the minimum washout period.

You may not qualify if:

• Women of childbearing potential if pregnant, test positive for pregnancy at Screening/Enrollment visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular hypertension.
• Diagnosed with severe central visual field loss in either eye.
• History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in either eye.
• History of ocular trauma within the past 6 months in either eye.
• Current ocular infection or ocular inflammation within the past 3 months in either eye.
• Ocular laser surgery within the past 3 months.
• Intraocular surgery within the past 3 months.
• Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
• History of, or current clinically relevant or progressive retinal disease in either eye.
• History of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker.
• Any abnormality preventing reliable applanation tonometry.
• History of, or current condition or disease that would preclude the safe administration of a topical beta blocker or topical beta-adrenergic blocking agent.
• History of spontaneous or current hypoglycemia or uncontrolled diabetes.
• History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any components of the study medication.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

brinzolamide; Timolol; Azarga; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Mandy Ye, Head, Clinical Trial Management, Asia
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3739

Study Officials

• Mandy Ye, MS

  Alcon Research

  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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 10, 2014
• Results First Posted: March 13, 2014

Record last verified: 2014-03