Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
Primary Purpose
Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trabodenoson 6.0% / latanoprost 0.005% QD
trabodenoson 3.0% / latanoprost 0.005% QD
trabodenoson 6.0% / latanoprost 0.0025% QD
latanoprost 0.005% QD
latanoprost 0.0025% QD
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:
- Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
- Mean Intraocular pressure (IOP) of ≥25 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
Sites / Locations
- Inotek Pharmaceuticals Corporation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
trabodenoson 6.0% /latanoprost 0.005% QD
trabodenoson 3.0% /latanoprost 0.005% QD
trabodenoson 6.0% /latanoprost 0.0025%QD
latanoprost 0.005% QD
latanoprost 0.0025% QD
Arm Description
trabodenoson 6.0% / latanoprost 0.005% QD FDC
trabodenoson 3.0% / latanoprost 0.005% QD FDC
trabodenoson 6.0% /latanoprost 0.0025% QD FDC
latanoprost 0.005% ophthalmic solution QD
latanoprost 0.0025% ophthalmic solution QD
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP)
Daily change from diurnal baseline in IOP
Secondary Outcome Measures
Full Information
NCT ID
NCT02829996
First Posted
July 8, 2016
Last Updated
January 19, 2018
Sponsor
Inotek Pharmaceuticals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02829996
Brief Title
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
Official Title
Phase II, Randomized, Double-masked, Active-controlled Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Subjects With Ocular Hypertension or Primary Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 19, 2016 (Actual)
Primary Completion Date
May 24, 2017 (Actual)
Study Completion Date
May 31, 2017 (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
Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.
All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications (if washout is needed), including their routine glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active drug product. During the Treatment Period, study drug (Active and Placebo) eye drop applications will occur twice daily, in the morning and in the evening. The Treatment Period will be followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
The purpose of the study is to assess the overall benefit/risk profile of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.
Detailed Description
This is a phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dose combinations of trabodenoson and latanoprost in subjects with OHT or POAG.
The Primary Objective of this Trial is to evaluate the efficacy of different topical ocular doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. The Secondary Objective is to evaluate the tolerability and safety of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. the Hypotheses is that topical ocular co-administration of 3.0% or 6.0% trabodenoson plus latanoprost 0.0025% or 0.005% ophthalmic formulation will reduce IOP and be well-tolerated.
All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo (vehicle control matched to trabodenoson) is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a manner that is masked to the patient. The Treatment Period will be followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
To mimic what is generally seen in clinical trials, the number of subjects with ocular hypertension as their diagnosis will be limited to approximately 30% of the total subjects enrolled. Additionally, so the trial mirrors the general population demographics (so as to improve generalizability of the results) the proportion of African American subjects will be approximately 25% or less but not less than 12% of the total subjects enrolled.
The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%) one drop daily over two consecutive 4 week periods in subjects with POAG or OHT. Data collection will include efficacy (masked-IOPs), local (ophthalmic) and systemic tolerability and safety assessments
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
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trabodenoson 6.0% /latanoprost 0.005% QD
Arm Type
Experimental
Arm Description
trabodenoson 6.0% / latanoprost 0.005% QD FDC
Arm Title
trabodenoson 3.0% /latanoprost 0.005% QD
Arm Type
Experimental
Arm Description
trabodenoson 3.0% / latanoprost 0.005% QD FDC
Arm Title
trabodenoson 6.0% /latanoprost 0.0025%QD
Arm Type
Experimental
Arm Description
trabodenoson 6.0% /latanoprost 0.0025% QD FDC
Arm Title
latanoprost 0.005% QD
Arm Type
Active Comparator
Arm Description
latanoprost 0.005% ophthalmic solution QD
Arm Title
latanoprost 0.0025% QD
Arm Type
Active Comparator
Arm Description
latanoprost 0.0025% ophthalmic solution QD
Intervention Type
Drug
Intervention Name(s)
trabodenoson 6.0% / latanoprost 0.005% QD
Intervention Description
Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
trabodenoson 3.0% / latanoprost 0.005% QD
Intervention Description
Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
trabodenoson 6.0% / latanoprost 0.0025% QD
Intervention Description
Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% QD
Intervention Description
Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.0025% QD
Intervention Description
Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Description
Daily change from diurnal baseline in IOP
Time Frame
Two Months
Other Pre-specified Outcome Measures:
Title
Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.
Description
Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.
Time Frame
Through Study Completion, up to 9 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
Mean Intraocular pressure (IOP) of ≥25 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cadmus C Rich, MD,MBA,CPE
Organizational Affiliation
Inotek Pharmaceuticals Corp.
Official's Role
Study Director
Facility Information:
Facility Name
Inotek Pharmaceuticals Corporation
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
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