A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
NCT ID: NCT01917383
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2013-08-31
2014-09-30
Brief Summary
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Detailed Description
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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) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
Exclusion Criteria:
1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Trabodenoson
Ophthalmic eye drop
Latanoprost
Ophthalmic eye drop
Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Latanoprost
Ophthalmic eye drop
Timolol
Ophthalmic eye drop
Interventions
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Trabodenoson
Ophthalmic eye drop
Latanoprost
Ophthalmic eye drop
Timolol
Ophthalmic eye drop
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
Exclusion Criteria
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
18 Years
ALL
No
Sponsors
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Inotek Pharmaceuticals Corporation
INDUSTRY
Responsible Party
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Locations
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Chiltern
Bristol, Tennessee, United States
Countries
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Other Identifiers
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IPC-01-2013
Identifier Type: -
Identifier Source: org_study_id