Glaucoma
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Brief summary
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
Interventions
DRUGBrinzolamide 1% and timolol 0.5% fixed combination eye drops
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. * Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit. * Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening. * Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. * Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator. * Any abnormality preventing reliable applanation tonometry in either eye. * Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment. * Pregnant or lactating. * Participation in any other investigational study within 30 days of screening visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | Baseline, Week 8 | As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy | Week 8 | As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3 study centers in Taiwan.
Participants by arm
| Arm | Count |
|---|---|
| AZARGA Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Non-Compliance | 1 |
| Overall Study | Personal Reasons | 1 |
Baseline characteristics
| Characteristic | AZARGA |
|---|---|
| Age Continuous | 60 years STANDARD_DEVIATION 15 |
| Region of Enrollment Taiwan | 74 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.
Time frame: Baseline, Week 8
Population: Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AZARGA | Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | Baseline | 18.22 millimeters mercury (mmHg) | Standard Deviation 2.64 |
| AZARGA | Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | Change at Week 8 | -3.56 millimeters mercury (mmHg) | Standard Deviation 3.16 |
Secondary
Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy
As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.
Time frame: Week 8
Population: Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZARGA | Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy | 54.3 Percentage of Participants |