A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
NCT ID: NCT01123785
Last Updated: 2012-10-15
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
PHASE1/PHASE2
144 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Matched vehicle-control
Placebo
Matched vehicle-control
INO-8875
Adenosine agonist eye drop
INO-8875
eye drops for 14 days in one eye
Interventions
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INO-8875
eye drops for 14 days in one eye
Placebo
Matched vehicle-control
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 75 years.
3. 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. History of adult asthma or chronic obstructive pulmonary disease
5. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
18 Years
77 Years
ALL
No
Sponsors
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Inotek Pharmaceuticals Corporation
INDUSTRY
Responsible Party
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Locations
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Lugene Eye Institute
Glendale, California, United States
Countries
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Other Identifiers
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IPC-10-2009
Identifier Type: -
Identifier Source: org_study_id
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