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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; Drug: Placebo; Drug: travoprost 0.004% ophthalmic solution

• Registration Number: NCT03150160
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-12
• Study Start: 2017-09-21
• Primary Completion: 2017-12-04
• Study Completion: 2017-12-04
• Status Verified: 2018-10
• Results First Submitted: 2018-10-19
• Results First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Results First Posted: 2019-02-25
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simbrinza + Travatan	brinzolamide 1%/brimonidine 0.2% fixed combination	Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Simbrinza + Travatan	travoprost 0.004% ophthalmic solution	Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + Travatan	Placebo	Placebo + travoprost 0.004% ophthalmic solution
Placebo + Travatan	travoprost 0.004% ophthalmic solution	Placebo + travoprost 0.004% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Diurnal IOP at Week 6	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
Percent Change From Baseline in IOP at Week 6	Baseline, 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.
Mean Diurnal IOP at Week 6	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.
Percentage Change From Baseline in IOP for Each Time Point at Week 6	Baseline, 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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of