Glaucoma, Ocular Hypertension, Open-angle Glaucoma
Conditions
Keywords
Glaucoma, Ocular hypertension, Intraocular pressure (IOP), Open angle glaucoma, Pigment dispersion glaucoma, Pigmentary
Brief summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).
Interventions
DRUGBrinzolamide 1% / timolol 0.5% maleate fixed combination
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to sign an Informed Consent form. * Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye). * Be on a stable IOP lowering regimen within 30 days of Screening Visit. * IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1. * IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. * Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye. * Willing to follow instructions and able to attend required study visits. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known history of hypersensitivity to any component of the preparations used in this study. * Presence of primary or secondary glaucoma not listed in inclusion criterion #2. * History of ocular herpes simplex. * Abnormality preventing reliable applanation tonometry. * Corneal dystrophies. * Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. * Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit. * Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * Progressive retinal or optic nerve disease from any cause. * Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit. * Pregnant or lactating. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) | Baseline, Week 8 | IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg) | Week 8 | IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. |
Participant flow
Recruitment details
Participants were recruited from 8 study centers located in Canada.
Pre-assignment details
Of the 57 enrolled, 3 participants were exited as screen failures. This reporting group includes all participants who received study medication (54).
Participants by arm
| Arm | Count |
|---|---|
| AZARGA Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM) | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | DId not meet inclusion/exclusion criteri | 1 |
| Overall Study | Terminated by Sponsor | 1 |
Baseline characteristics
| Characteristic | AZARGA |
|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 10.37 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 1 / 54 |
Outcome results
Primary
Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time frame: Baseline, Week 8
Population: This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AZARGA | Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) | Baseline | 22.24 mmHg | Standard Deviation 3.15 |
| AZARGA | Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) | Change from baseline at Week 8 | -2.24 mmHg | Standard Deviation 3.928 |
Secondary
Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time frame: Week 8
Population: This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZARGA | Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg) | 36.2 percentage of participants |