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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.
This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simbrinza + Travatan | Experimental | Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution |
|
| Placebo + Travatan | Placebo Comparator | Placebo + travoprost 0.004% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brinzolamide 1%/brimonidine 0.2% fixed combination | Drug | One drop applied topically to the affected eye(s) in the morning and evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Diurnal IOP at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Seoul | 03080 | South Korea |
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All randomized patients (1). Note: No patients were randomized to the Simbrinza + Travatan arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simbrinza + Travatan | Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) |
| FG001 | Placebo + Travatan | Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2018 | Oct 19, 2018 |
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.
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| Placebo | Drug | One drop applied topically to the affected eye(s) in the morning and evening |
|
| travoprost 0.004% ophthalmic solution | Drug | One drop applied topically to the affected eye(s) in the evening |
|
|
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 |
| 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) |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
|
No patients were enrolled in the Simbrinza + Travatan arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simbrinza + Travatan | Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) |
| BG001 | Placebo + Travatan | Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 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. | 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. | Posted | Baseline, Week 6 |
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| ||||||||||||||||||||||
| 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | Baseline, Week 6 |
|
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simbrinza + Travatan | Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Placebo + Travatan | Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) | 0 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| common cold | Infections and infestations | MedDRA v. 20 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2017 | Oct 19, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|