Glaucoma
Conditions
Keywords
travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety
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.
Interventions
DRUGbrinzolamide 1%/brimonidine 0.2% fixed combination
One drop applied topically to the affected eye(s) in the morning and evening
DRUGPlacebo
One drop applied topically to the affected eye(s) in the morning and evening
One drop applied topically to the affected eye(s) in the evening
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
South Korea
Participant flow
Pre-assignment details
All randomized patients (1). Note: No patients were randomized to the Simbrinza + Travatan arm.
Participants by arm
| Arm | Count |
|---|---|
| Simbrinza + Travatan Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) | 0 |
| Placebo + Travatan Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Simbrinza + Travatan | Placebo + Travatan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 1 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: Baseline, Week 6
Population: 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.
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.
Time frame: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
Population: 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.
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.
Time frame: Week 6
Population: 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.
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.
Time frame: Baseline, Week 6
Population: 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.
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.
Time frame: Baseline, Week 6
Population: 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.