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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01357616 | Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 328 | — | — | Nov 1, 2010 | Jan 1, 2013 | Apr 10, 2014 | - | — |
| NCT00314158 | A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 523 | — | — | Nov 1, 2005 | Jan 1, 2007 | Nov 18, 2016 | 1 | United States |
Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..
| Arm | Type | Description |
|---|---|---|
| AZARGA | EXPERIMENTAL | Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| AZOPT + Timolol | ACTIVE_COMPARATOR | Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| Brinzolamide +Timolol | EXPERIMENTAL | - |
| Brinzolamide | ACTIVE_COMPARATOR | - |
| Timolol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension | DRUG | - |
| Brinzolamide 1% ophthalmic suspension | DRUG | - |
| Timolol 0.5% ophthalmic solution | DRUG | - |
| Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Timolol 5 mg/ml eye drops, solution | DRUG | One drop twice daily in each study eye for six months |
Inclusion Criteria: * Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy. * Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit. * Willing to sign an Informed Consent form. * Contact lens wearer who ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |