Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01863953 | A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension | PHASE2 | COMPLETED | 112 | — | — | Jun 1, 2013 | Dec 1, 2013 | Jan 26, 2015 | 1 | United States |
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
| Arm | Type | Description |
|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | EXPERIMENTAL | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | ACTIVE_COMPARATOR | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | ACTIVE_COMPARATOR | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | DRUG | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| Bimatoprost Ophthalmic Solution 0.01% | DRUG | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks. |
| Vehicle Ophthalmic Solution | DRUG | One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | DRUG | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
Inclusion Criteria: * Diagnosis of ocular hypertension or glaucoma * Requires intraocular pressure (IOP)-lowering therapy Exclusion Criteria: * Cataract surgery in one eye * Ocular laser or intraocular surgery within 6 months * Refractive surgery in either eye * Anticipated use of contact lenses ...