Status:
COMPLETED
A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Lead Sponsor:
Inotek Pharmaceuticals Corporation
Conditions:
Primary Open-Angle Glaucoma (POAG)
Ocular Hypertension (OHT)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate oph...
Detailed Description
Criteria Inclusion Criteria: 1. Subject has signed and dated the current informed consent form (ICF). 2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) ...
Eligibility Criteria
Inclusion
- Subject has signed and dated the current informed consent form (ICF).
- Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
- Aged 18 or older.
- Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
Exclusion
- No significant visual field loss or any new field loss within the past year.
- Cup-to-disc ratio ≥0.8
- Central corneal thickness \<500 µm or \>600 µm
- A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01917383
Start Date
August 1 2013
End Date
September 1 2014
Last Update
December 2 2017
Active Locations (1)
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1
Chiltern
Bristol, Tennessee, United States, 37620