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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT02565173 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
MATrX-1 |
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Scientific title:
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Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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303 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02565173 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Cadmus C Rich, MD,MBA,CPE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inotek Pharmaceuticals Corp. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Open-Angle Glaucoma (POAG)
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Ocular Hypertension (OHT)
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Intervention(s)
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Drug: placebo BID
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Drug: trabodenoson 3.0% QD
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Drug: trabodenoson 6.0% QD
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Drug: trabodenoson 4.5% BID
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Drug: timolol 0.5% BID
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Primary Outcome(s)
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Mean Intraocular Pressure (IOP)
[Time Frame: Three Months]
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Secondary ID(s)
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IPC-01-2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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