Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | October 2016 |
| Contact: | Thomas Feinberg |
| Email: | tfeinberg@inotekpharma.com |
| Phone: | 781-676-2112 |
Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
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.
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.
Inclusion Criteria:
- Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
- Mean Intraocular pressure (IOP) of ≥24 and ≤34
Exclusion Criteria:
- Significant visual field loss or any new field loss within the past year
- Cup-to-disc ratio >0.8
- Central corneal thickness <490 µm or >610 µm
- A recent (acute) or chronic medical condition that might obfuscate the Subject's
study data
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