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This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 - Arm 1 - Dose 1 | Experimental |
| |
| Stage 1 - Arm 2 - Dose 2 | Experimental |
| |
| Stage 1 - Arm 3 - Dose 3 | Experimental |
| |
| Stage 1 - Arm 4 - Dose 4 | Experimental |
| |
| Stage 1 - Arm 5 - Vehicle | Placebo Comparator |
| |
| Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1 | Experimental |
| |
| Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stage 1 - ATS907 - Dose 1 | Drug | QD and/or BID dosing for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intraocular Pressure from Baseline | Stage 1: Days 14, 21 and 28; Stage 2: Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Intraocular Pressure and % change from Baseline IOP | Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4 | |
| Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP | Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4 |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic (in either eye)
Systemic
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Wirostko, MD | Altheos, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| Stage 2 - Arm 3 -Timoptic 0.5% BID | Active Comparator |
|
| Stage 1 - ATS907 - Dose 2 |
| Drug |
QD and/or BID dosing for 28 days |
|
| Stage 1 - ATS907 - Dose 3 | Drug | QD and/or BID dosing for 28 days |
|
| Stage 1 - ATS907 - Dose 4 | Drug | QD and/or BID dosing for 28 days |
|
| Stage 1 - Vehicle | Drug | QD and/or BID dosing for 28 days |
|
| Stage 2 - ATS907 - Dose A - to be selected based on Stage 1 | Drug | QD and/or BID dosing for 4 days |
|
| Stage 2 - ATS907 - Dose B - to be selected based on Stage 1 | Drug | QD and/or BID dosing for 4 days |
|
| Timoptic | Drug | 0.5% |
|
| Glendale |
| California |
| United States |
| Saint Joseph | Michigan | United States |
| Cleveland | Ohio | United States |
| San Antonio | Texas | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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