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 participants with open-angle glaucoma or ocular hypertension.
Interventions
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
* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye). * On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit. * IOP considered safe in both eyes in order to 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. * History of ocular herpes simplex. * Any 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 Screening Visit. * Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator. * 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 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 |
|---|---|---|
| Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 | Baseline, Week 8 | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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) at Week 8 | Week 8 | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).
Pre-assignment details
This reporting group includes all participants who received at least one dose of AZARGA®.
Participants by arm
| Arm | Count |
|---|---|
| AZARGA® Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | AZARGA® |
|---|---|
| Age, Continuous | 66.67 years STANDARD_DEVIATION 11.51 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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: The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZARGA® | Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 | -3.60 milllimeters mercury (mmHg) | Standard Deviation 3.01 |
Secondary
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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: The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZARGA® | Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8 | 55.3 percentage of participants |