Primary Open-Angle Glaucoma (POAG)Phase 3MATrX-1NCT02565173
Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
A Phase 3 study testing trabodenoson 4.5% BID, trabodenoson 6.0% QD and trabodenoson 3.0% QD in people with Primary Open-Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Inotek Pharmaceuticals Corporation at 1 site in United States.
Trial summary
Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma (POAG), Ocular Hypertension (OHT)
- What is being tested?
- trabodenoson 4.5% BID, trabodenoson 6.0% QD and trabodenoson 3.0% QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
- Mean Intraocular pressure (IOP) of ≥24 and ≤34
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inotek Pharmaceuticals Corporation
Lexington, Massachusetts, 02421
About this study
Official title: Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult 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, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
Read more
The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.
Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.
- Being tested
- trabodenoson 4.5% BID, trabodenoson 6.0% QD, trabodenoson 3.0% QD, timolol 0.5% BID, placebo BID
- Keywords
- glaucoma, primary open-angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabodenoson 4.5% BIDDrug
Also called INO-8875
Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
trabodenoson 6.0% QDDrug
Also called INO-8875
Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
trabodenoson 3.0% QDDrug
Also called INO-8875
Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
timolol 0.5% BIDDrug
Also called Timoptic
Timolol 0.5% administered twice per day in both eyes for 12 weeks.
placebo BIDDrug
Placebo administered twice per day in both eyes for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| trabodenoson 4.5% BID | Experimental | trabodenoson 4.5% Ophthalmic Formulation Receives: Drug: trabodenoson 4.5% BID |
| trabodenoson 6.0% QD | Experimental | trabodenoson 6.0% Ophthalmic Formulation Receives: Drug: trabodenoson 6.0% QD |
| trabodenoson 3.0% QD | Experimental | trabodenoson 3.0% Ophthalmic Formulation Receives: Drug: trabodenoson 3.0% QD |
| timolol 0.5% BID | Active comparator | timolol 0.5% Ophthalmic Formulation Receives: Drug: timolol 0.5% BID |
| placebo BID | Placebo comparator | placebo Ophthalmic Formulation Receives: Drug: placebo BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotek Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cadmus C Rich, MD,MBA,CPE, Study director, Inotek Pharmaceuticals Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565173
- Sponsor's protocol ID
- IPC-01-2015
- Acronym
- MATrX-1
- Status last verified
- Dec 2016
- First submitted
- 28 Sep 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT02565173
- Acronym / sponsor ID
- MATrX-1 / IPC-01-2015
- Keywords
- glaucoma, primary open-angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult 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, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks 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 efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.
Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| trabodenoson 4.5% BID | Experimental | Drug: trabodenoson 4.5% BIDtrabodenoson 4.5% Ophthalmic Formulation |
| trabodenoson 6.0% QD | Experimental | Drug: trabodenoson 6.0% QDtrabodenoson 6.0% Ophthalmic Formulation |
| trabodenoson 3.0% QD | Experimental | Drug: trabodenoson 3.0% QDtrabodenoson 3.0% Ophthalmic Formulation |
| timolol 0.5% BID | Active comparator | Drug: timolol 0.5% BIDtimolol 0.5% Ophthalmic Formulation |
| placebo BID | Placebo comparator | Drug: placebo BIDplacebo Ophthalmic Formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
- Mean Intraocular pressure (IOP) of ≥24 and ≤34
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trabodenoson 4.5% BIDAlso: INO-8875Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks. | Drug | trabodenoson 4.5% BID |
| trabodenoson 6.0% QDAlso: INO-8875Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks. | Drug | trabodenoson 6.0% QD |
| trabodenoson 3.0% QDAlso: INO-8875Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks. | Drug | trabodenoson 3.0% QD |
| timolol 0.5% BIDAlso: TimopticTimolol 0.5% administered twice per day in both eyes for 12 weeks. | Drug | timolol 0.5% BID |
| placebo BIDPlacebo administered twice per day in both eyes for 12 weeks. | Drug | placebo BID |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: Three Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
Related trials for Primary Open-Angle Glaucoma (POAG)
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cadmus C Rich, MD,MBA,CPE study director
Inotek Pharmaceuticals Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trabodenoson 4.5% BID, trabodenoson 6.0% QD and trabodenoson 3.0% QD in people with Primary Open-Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Inotek Pharmaceuticals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intraocular Pressure (IOP) (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.