Clinical trial NCT03150160: Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: travoprost
brinzolamide 1%/brimonidine 0.2%
normal tension glaucoma
intraocular pressure
efficacy
safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline in Diurnal IOP at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percent Change From Baseline in IOP at Week 6
timeFrame: Baseline, Week 6
measure: Mean Diurnal IOP at Week 6
timeFrame: Week 6
measure: Mean Change From Baseline in IOP for Each Time Point at Week 6
timeFrame: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
measure: Percentage Change From Baseline in IOP for Each Time Point at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: