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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

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ClinicalTrials.gov Identifier: NCT03150160
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Glaucoma
Interventions Drug: brinzolamide 1%/brimonidine 0.2% fixed combination
Drug: Placebo
Drug: travoprost 0.004% ophthalmic solution
Enrollment 1
Recruitment Details  
Pre-assignment Details All randomized patients (1). Note: No patients were randomized to the Simbrinza + Travatan arm.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Simbrinza + Travatan Placebo + Travatan Total
Hide Arm/Group Description Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
No patients were enrolled in the Simbrinza + Travatan arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0
0
   0.0%
0
   0.0%
Between 18 and 65 years 0
0
   0.0%
0
   0.0%
>=65 years 0
1
 100.0%
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 0
0
   0.0%
0
   0.0%
Male 0
1
 100.0%
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Hispanic or Latino 0
0
   0.0%
0
   0.0%
Not Hispanic or Latino 0
1
 100.0%
1
 100.0%
Unknown or Not Reported 0
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change From Baseline in Diurnal IOP at Week 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + travoprost 0.004% ophthalmic solution
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percent Change From Baseline in IOP at Week 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + travoprost 0.004% ophthalmic solution
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Diurnal IOP at Week 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + travoprost 0.004% ophthalmic solution
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Mean Change From Baseline in IOP for Each Time Point at Week 6
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + travoprost 0.004% ophthalmic solution
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage Change From Baseline in IOP for Each Time Point at Week 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Placebo + travoprost 0.004% ophthalmic solution
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately six weeks.
Adverse Event Reporting Description The Safety analysis set included all patients exposed to at least one dose of any study therapy. Note: Number at risk for Simbrinza + Travatan is reported as 0 because no patients were exposed to this study therapy.
 
Arm/Group Title Simbrinza + Travatan Placebo + Travatan
Hide Arm/Group Description Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
All-Cause Mortality
Simbrinza + Travatan Placebo + Travatan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Simbrinza + Travatan Placebo + Travatan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simbrinza + Travatan Placebo + Travatan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   1/1 (100.00%) 
Infections and infestations     
common cold  1  0/0  1/1 (100.00%) 
1
Term from vocabulary, MedDRA v. 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 1-862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03150160     History of Changes
Other Study ID Numbers: CQVJ499A2404
First Submitted: May 9, 2017
First Posted: May 12, 2017
Results First Submitted: October 19, 2018
Results First Posted: February 25, 2019
Last Update Posted: February 25, 2019