Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty with patient recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBIGAN® with Latanoprost | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 6 |
| Percentage of Responders With an IOP Reduction ≥20% From Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
Not provided
Due to lack of enrollment, this study was discontinued early.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Baseline, Week 12 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Erosion | Eye disorders | Systematic Assessment |
Due to lack of enrollment, this study was discontinued early and the outcome measures were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D013999 | Timolol |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| latanoprost | Drug | Latanoprost administered in the affected eye(s) as prescribed by physician. |
|
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. |
| Baseline, Week 12 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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. | 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. | Posted | Baseline, Week 2, Week 6 |
|
|
| 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. | 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. | Posted | Baseline, Week 12 |
|
|
| 0 |
| 17 |
| 5 |
| 17 |
| Conjunctival Hyperemia | Eye disorders | Systematic Assessment |
|
| Somnolent | Nervous system disorders | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |