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The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBIGAN® | Experimental | One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months |
|
| COMBIGAN® + LUMIGAN® 0.01% | Experimental | LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine tartrate/timolol malate Ophthalmic Solution | Drug | One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP change from Baseline (11AM point) | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP change from Baseline (11AM point) | Mean IOP change from baseline (11AM point) in the following patient sub-groups
| Baseline, Month 12 |
| Mean IOP change from Baseline (9AM point) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy Maglambayan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital, Pusan National University School of Medicine | Busan | 49241 | South Korea | |||
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| bimatoprost ophthalmic solution 0.01% | Drug | Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed |
|
Mean IOP change from baseline (9AM point) in the following patient sub-groups
|
| Baseline, Month 12 |
| Mean change in Mean deviation (MD) from Baseline | Baseline, Month 12 |
| Mean change in Pattern standard deviation (PSD) from Baseline | Baseline, Month 12 |
| Mean change in Visual field index (VFI) from Baseline | Baseline, Month 12 |
| Mean change in cup to disc ratio (C/D ratio) from Baseline | Baseline, Month 12 |
| Rate of VF progression measured as change in VF index over time | Rate of VF progression during 12 months in the following patient sub-groups.
| Baseline, Month 12 |
| Mean duration of achieving the target IOP with COMBIGAN® alone | 12 Months |
| The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months | 12 Months |
| Definition of patient demographics (descriptive analysis of age and gender) | Define patient demographics in the following patient sub-groups:
| Baseline, Month 12 |
| Yeungnam University Hospital, Yeungnam University College of Medicine |
| Daegu |
| 42415 |
| South Korea |
| Chungnam National University Hospital, Chungnam National University College of Medicine | Daejeon | 35015 | South Korea |
| Chonnam National University Hospital, Chonnam National University Medical School | Gwangju | 61469 | South Korea |
| Seoul National University Bundang Hospital, Seoul National University College of Medicine | Gyeonggi-do | 13619 | South Korea |
| Seoul National University Hospital, Seoul National University College of Medicine | Seoul | 03080 | South Korea |
| Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | 03181 | South Korea |
| Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine | Seoul | 06591 | South Korea |
| Kim's Eye Hospital, Konyang University College of Medicine | Seoul | 07301 | South Korea |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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