Glaucoma, Ocular Hypertension
Conditions
Keywords
AZARGA®, Open angle glaucoma, Prostaglandin Therapy
Brief summary
The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
Detailed description
This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.
Interventions
DRUGBrinzolamide 1% / timolol 0.5% Fixed Combination
DRUGHabitual prostaglandin monotherapy
Topical ocular therapy used daily as prescribed
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, primary open angle (including pigment dispersion) glaucoma in both eyes. * 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. * Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1. * At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy. * Best corrected visual acuity of 1.0 LogMAR or better in each eye. * In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone. * Willing to sign an informed consent form. * Able to follow instructions and willing and able to attend required study visits. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator. * A history of, or at risk for uveitis or cystoid macular edema (CME). * History of ocular herpes simplex. * Corneal dystrophies in either eye. * Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia). * Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1. * 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 apart from glaucoma. * Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study. * Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study. * Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * History of severe allergic rhinitis. * A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. * Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide \[Neptazane\], acetazolamide \[Diamox\]). * Severely impared renal function. * History of an allergy to sulphonamides. * Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control. * Any clinically significant, serious, or severe medical condition. * Participation in any other investigational study within 30 days prior to the screening/baseline visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | 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. Only one eye (study eye) contributed to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12 | Baseline, Week 12 | 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. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean. |
| Mean Change From Baseline in IOP at Week 4 | Baseline, Week 4 | 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. Only one eye (study eye) contributed to the mean. |
| Percentage of Patients Reaching the Target IOP (≤ 18 mmHg) | Week 12 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed. |
Participant flow
Recruitment details
Participants were recruited from 3 study centers located in Austria and 2 study centers located in Spain.
Pre-assignment details
This reporting group includes all enrolled participants (47).
Participants by arm
| Arm | Count |
|---|---|
| Azarga Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Azarga |
|---|---|
| Age, Customized ≤55 Years | 3 participants |
| Age, Customized 56-65 Years | 10 participants |
| Age, Customized 66-75 Years | 25 participants |
| Age, Customized ≥ 76 Years | 9 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 1 / 47 |
Outcome results
Primary
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
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. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 12
Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azarga | Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12 | -6.0 mmHg | Standard Deviation 3.2 |
Secondary
Mean Change From Baseline in IOP at Week 4
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. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 4
Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azarga | Mean Change From Baseline in IOP at Week 4 | -6.0 mmHg | Standard Deviation 3.2 |
Secondary
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
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. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 12
Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azarga | Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12 | AZARGA + Latanoprost (n=22) | -7.1 mmHg | Standard Deviation 2.9 |
| Azarga | Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12 | AZARGA + Travoprost (n=15) | -5.1 mmHg | Standard Deviation 3.4 |
Secondary
Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
Time frame: Week 12
Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azarga | Percentage of Patients Reaching the Target IOP (≤ 18 mmHg) | 70.0 percentage of participants |