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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150160
• Other study ID #: CQVJ499A2404
• Status: Completed
• Phase: Phase 4
• Start date: September 21, 2017
• Est. completion date: December 4, 2017

Study information

• Verified date: October 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 4, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma

Intervention

Drug:
• brinzolamide 1%/brimonidine 0.2% fixed combination
One drop applied topically to the affected eye(s) in the morning and evening
• Placebo
One drop applied topically to the affected eye(s) in the morning and evening
• travoprost 0.004% ophthalmic solution
One drop applied topically to the affected eye(s) in the evening

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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