Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma

A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma

The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; Drug: travoprost 0.004% ophthalmic solution; Drug: Placebo

Detailed Description

This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign written informed consent
• Diagnosed with normal tension glaucoma
• Intraocular pressure measurements in at least 1 eye as specified in the protocol
• Willing and able to attend all study visits

Exclusion Criteria:

• History of hypersensitivity to any of the study drugs
• Use of medications prohibited by the protocol
• Pregnant or nursing
• Of child-bearing potential unless using contraception, as specified in the protocol
• Any form of glaucoma other than open angle glaucoma in either eye
• Chronic, recurrent or severe inflammatory eye disease
• Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
• Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simbrinza + Travatan; Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution	Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; One drop applied topically to the affected eye(s) in the morning and evening; Other Names: Simbrinza; Drug: travoprost 0.004% ophthalmic solution; One drop applied topically to the affected eye(s) in the evening; Other Names: Travatan
Placebo Comparator: Placebo + Travatan; Placebo + travoprost 0.004% ophthalmic solution	Drug: travoprost 0.004% ophthalmic solution; One drop applied topically to the affected eye(s) in the evening; Other Names: Travatan; Drug: Placebo; One drop applied topically to the affected eye(s) in the morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Diurnal IOP at Week 6	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in IOP at Week 6	IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Mean Diurnal IOP at Week 6	IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.	Week 6
Mean Change From Baseline in IOP for Each Time Point at Week 6	IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.	Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
Percentage Change From Baseline in IOP for Each Time Point at Week 6	IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): December 4, 2017

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: safety; efficacy; intraocular pressure; travoprost; brinzolamide 1%/brimonidine 0.2%; normal tension glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Low Tension Glaucoma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Brimonidine Tartrate; Ophthalmic Solutions; Travoprost; Brinzolamide
• Other Study ID Numbers: CQVJ499A2404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No