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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01157364 | Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension | PHASE1 | COMPLETED | 109 | — | — | Sep 23, 2010 | Aug 9, 2016 | Mar 30, 2020 | 57 | United States, Australia +8 |
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| bimatoprost 20 µg generation 2, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 15 µg generation 2, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 10 µg generation 2, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 6 µg generation 2, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 15 µg generation 1, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 10 µg generation 1, bimatoprost 0.03% | OTHER | Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| bimatoprost 20 µg generation 2 | DRUG | Single dose of bimatoprost ophthalmic administered in the study eye on Day 1. |
| bimatoprost 15 µg generation 2 | DRUG | Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). |
| bimatoprost 10 µg generation 2 | DRUG | Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). |
| bimatoprost 6 µg generation 2 | DRUG | Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). |
| bimatoprost 15 µg generation 1 | DRUG | Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. |
| bimatoprost 10 µg generation 1 | DRUG | Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. |
| bimatoprost 0.03% | DRUG | One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
Inclusion Criteria: * Diagnosis of open angle glaucoma or ocular hypertension Exclusion Criteria: * Uncontrolled medical conditions * Anticipated wearing of contact lenses during the study
| 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 |