Glaucoma, Angle-Closure
Conditions
Brief summary
This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.
Interventions
COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
DRUGlatanoprost
Latanoprost administered in the affected eye(s) as prescribed by physician.
Sponsors
Allergan
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
* Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study * Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops * Diagnosis of chronic angle-closure glaucoma * Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.
Exclusion criteria
* Known allergy or hypersensitivity to COMBIGAN® * Corneal abnormalities that would preclude accurate IOP readings * Any other active ocular disease other than glaucoma or ocular hypertension * Ocular surgery within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, Week 12 | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in IOP | Baseline, Week 2, Week 6 | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure. |
| Percentage of Responders With an IOP Reduction ≥20% From Baseline | Baseline, Week 12 | IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure. |
Countries
Thailand
Participant flow
Recruitment details
Due to lack of enrollment, this study was discontinued early.
Participants by arm
| Arm | Count |
|---|---|
| COMBIGAN® With Latanoprost Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | COMBIGAN® With Latanoprost |
|---|---|
| Age, Customized <45 years | 0 Participants |
| Age, Customized >65 years | 10 Participants |
| Age, Customized Between 45 and 65 years | 7 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time frame: Baseline, Week 12
Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.
Secondary
Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time frame: Baseline, Week 2, Week 6
Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.
Secondary
Percentage of Responders With an IOP Reduction ≥20% From Baseline
IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.
Time frame: Baseline, Week 12
Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.