Back to resultsA Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Primary Purpose
Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trabodenoson
Latanoprost
Timolol
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-Angle Glaucoma (POAG) focused on measuring glaucoma, primary open angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Chiltern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trabodenoson Plus Latanoprost
Timolol Plus Latanoprost
Arm Description
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
NCT ID
NCT01917383
First Posted
August 5, 2013
Last Updated
November 28, 2017
Sponsor
Inotek Pharmaceuticals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01917383
Brief Title
A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Official Title
A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inotek Pharmaceuticals Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).
Detailed Description
Criteria
Inclusion Criteria:
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 Criteria:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Keywords
glaucoma, primary open angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trabodenoson Plus Latanoprost
Arm Type
Experimental
Arm Description
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Arm Title
Timolol Plus Latanoprost
Arm Type
Active Comparator
Arm Description
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Intervention Type
Drug
Intervention Name(s)
Trabodenoson
Other Intervention Name(s)
INO-8875
Intervention Description
Ophthalmic eye drop
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Other Intervention Name(s)
Xalatan
Intervention Description
Ophthalmic eye drop
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timoptic
Intervention Description
Ophthalmic eye drop
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Chiltern
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
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