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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
brinzolamide 1%/brimonidine 0.2% fixed combination
Placebo
travoprost 0.004% ophthalmic solution
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simbrinza + Travatan

Placebo + Travatan

Arm Description

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

Placebo + travoprost 0.004% ophthalmic solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 9, 2017
Last Updated
October 19, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03150160
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simbrinza + Travatan
Arm Type
Experimental
Arm Description
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Arm Title
Placebo + Travatan
Arm Type
Placebo Comparator
Arm Description
Placebo + travoprost 0.004% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
brinzolamide 1%/brimonidine 0.2% fixed combination
Other Intervention Name(s)
Simbrinza
Intervention Description
One drop applied topically to the affected eye(s) in the morning and evening
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One drop applied topically to the affected eye(s) in the morning and evening
Intervention Type
Drug
Intervention Name(s)
travoprost 0.004% ophthalmic solution
Other Intervention Name(s)
Travatan
Intervention Description
One drop applied topically to the affected eye(s) in the evening
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Diurnal IOP at Week 6
Description
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 Outcome Measure Information:
Title
Percent Change From Baseline in IOP at Week 6
Description
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
Title
Mean Diurnal IOP at Week 6
Description
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
Title
Mean Change From Baseline in IOP for Each Time Point at Week 6
Description
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)
Title
Percentage Change From Baseline in IOP for Each Time Point at Week 6
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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