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Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL1107 Low dose | Experimental |
| |
| BL1107 High dose | Experimental |
| |
| Timolol maleate 0.5% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL1107 Low dose | Drug | Dosed twice daily for 28 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. | Assessed at Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. | Assessed at Day 28 | |
| Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management, Inc. | Glendale | California | 91204 | United States | ||
| Eye Research Foundation |
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| BL1107 High dose |
| Drug |
Dosed twice daily for 28 days. |
|
| Timolol maleate 0.5% | Drug | Dosed twice daily for 28 days. |
|
| Assessed at Day 28 |
| Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit. | Assessed at Day 28 |
| Newport Beach |
| California |
| 92663 |
| United States |
| California Eye Specialist Medical Group, LLC | Pasadena | California | 91107 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Central Florida Eye Associates | Lakeland | Florida | 33805 | United States |
| Lee Shettle Eye and Hearing | Largo | Florida | 33773 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Heart of America Eye Care | Shawnee Mission | Kansas | 66204 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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