Glaucoma
Conditions
Keywords
Primary open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Brief summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
Interventions
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
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
* 18 years of age or older. * Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye). * Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit. * IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period. * Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye. * IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Presence of other primary or secondary glaucoma not listed in inclusion criteria #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 three 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. * Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study. * Pregnant or lactating. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). | 8 weeks | Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZARGA Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | AZARGA |
|---|---|
| Age Continuous | 58.56 years STANDARD_DEVIATION 15.83 |
| Region of Enrollment Brazil | 9 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZARGA | Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). | -0.89 millimeters mercury (mmHg) | Standard Deviation 4.14 |