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

Novartis Pharmaceuticals1 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma

Interventions

brinzolamide 1%/brimonidine 0.2% fixed combinationDRUG

One drop applied topically to the affected eye(s) in the morning and evening

PlaceboDRUG

One drop applied topically to the affected eye(s) in the morning and evening

travoprost 0.004% ophthalmic solutionDRUG

One drop applied topically to the affected eye(s) in the evening

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.