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

NCT03150160 | Completed Phase 4 Results

• 1 other identifier: CQVJ499A2404
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

travoprost; brinzolamide 1%/brimonidine 0.2%; normal tension glaucoma; intraocular pressure; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent Change From Baseline in IOP at Week 6

  Baseline, Week 6

• Mean Diurnal IOP at Week 6

  Week 6

• Mean Change From Baseline in IOP for Each Time Point at Week 6

  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

  Baseline, Week 6

Study Arms (2)

Simbrinza + Travatan

EXPERIMENTAL

Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution

Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; Drug: travoprost 0.004% ophthalmic solution

Placebo + Travatan

PLACEBO COMPARATOR

Placebo + travoprost 0.004% ophthalmic solution

Drug: Placebo; Drug: travoprost 0.004% ophthalmic solution

Interventions

brinzolamide 1%/brimonidine 0.2% fixed combination DRUG

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

Also known as: Simbrinza

Simbrinza + Travatan

Placebo DRUG

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

Placebo + Travatan

travoprost 0.004% ophthalmic solution DRUG

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

Also known as: Travatan

Placebo + Travatan; Simbrinza + Travatan

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Glaucoma; Low Tension Glaucoma

Interventions

brinzolamide; Brimonidine Tartrate; Travoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

1-862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: September 21, 2017
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: February 25, 2019
• Results First Posted: February 25, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)