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Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.
All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.
Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trabodenoson 4.5% BID | Experimental | trabodenoson 4.5% Ophthalmic Formulation |
|
| trabodenoson 6.0% QD | Experimental | trabodenoson 6.0% Ophthalmic Formulation |
|
| trabodenoson 3.0% QD | Experimental | trabodenoson 3.0% Ophthalmic Formulation |
|
| timolol 0.5% BID | Active Comparator | timolol 0.5% Ophthalmic Formulation |
|
| placebo BID | Placebo Comparator | placebo Ophthalmic Formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trabodenoson 4.5% BID | Drug | Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) | Three Months |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety. | Through Study Completion, up to 13 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cadmus C Rich, MD,MBA,CPE | Inotek Pharmaceuticals Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inotek Pharmaceuticals Corporation | Lexington | Massachusetts | 02421 | United States |
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| trabodenoson 6.0% QD | Drug | Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks. |
|
|
| trabodenoson 3.0% QD | Drug | Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks. |
|
|
| timolol 0.5% BID | Drug | Timolol 0.5% administered twice per day in both eyes for 12 weeks. |
|
|
| placebo BID | Drug | Placebo administered twice per day in both eyes for 12 weeks. |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000624504 | trabodenoson |
| C494814 | BID protein, human |
| C578457 | INO-8875 |
| 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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