Primary Open-Angle Glaucoma (POAG)Phase 2NCT02829996
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
A Phase 2 study testing trabodenoson 6.0% / latanoprost 0.005% QD, trabodenoson 3.0% / latanoprost 0.005% QD and trabodenoson 6.0% / latanoprost 0.0025% 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 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. 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 6.0% / latanoprost 0.005% QD, trabodenoson 3.0% / latanoprost 0.005% QD and trabodenoson 6.0% / latanoprost 0.0025% QD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2016to 31 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ≥25 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 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
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.
Read the 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
- Being tested
- 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
- 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 6.0% / latanoprost 0.005% QDDrug
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.
trabodenoson 3.0% / latanoprost 0.005% QDDrug
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.
trabodenoson 6.0% / latanoprost 0.0025% QDDrug
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.
latanoprost 0.005% QDDrug
Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
latanoprost 0.0025% QDDrug
Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| trabodenoson 6.0% /latanoprost 0.005% QD | Experimental | trabodenoson 6.0% / latanoprost 0.005% QD FDC Receives: Drug: trabodenoson 6.0% / latanoprost 0.005% QD |
| trabodenoson 3.0% /latanoprost 0.005% QD | Experimental | trabodenoson 3.0% / latanoprost 0.005% QD FDC Receives: Drug: trabodenoson 3.0% / latanoprost 0.005% QD |
| trabodenoson 6.0% /latanoprost 0.0025%QD | Experimental | trabodenoson 6.0% /latanoprost 0.0025% QD FDC Receives: Drug: trabodenoson 6.0% / latanoprost 0.0025% QD |
| latanoprost 0.005% QD | Active comparator | latanoprost 0.005% ophthalmic solution QD Receives: Drug: latanoprost 0.005% QD |
| latanoprost 0.0025% QD | Active comparator | latanoprost 0.0025% ophthalmic solution QD Receives: Drug: latanoprost 0.0025% QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Daily change from diurnal baseline in IOP
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start19 Aug 2016
- Primary completion24 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 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
- NCT02829996
- Sponsor's protocol ID
- IPC-02-2015
- Status last verified
- Jan 2018
- First submitted
- 8 Jul 2016
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02829996
- Acronym / sponsor ID
- IPC-02-2015
- Keywords
- glaucoma, primary open-angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2016 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 15 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 6.0% /latanoprost 0.005% QD | Experimental | Drug: trabodenoson 6.0% / latanoprost 0.005% QDtrabodenoson 6.0% / latanoprost 0.005% QD FDC |
| trabodenoson 3.0% /latanoprost 0.005% QD | Experimental | Drug: trabodenoson 3.0% / latanoprost 0.005% QDtrabodenoson 3.0% / latanoprost 0.005% QD FDC |
| trabodenoson 6.0% /latanoprost 0.0025%QD | Experimental | Drug: trabodenoson 6.0% / latanoprost 0.0025% QDtrabodenoson 6.0% /latanoprost 0.0025% QD FDC |
| latanoprost 0.005% QD | Active comparator | Drug: latanoprost 0.005% QDlatanoprost 0.005% ophthalmic solution QD |
| latanoprost 0.0025% QD | Active comparator | Drug: latanoprost 0.0025% QDlatanoprost 0.0025% ophthalmic solution QD |
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 ≥25 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 6.0% / latanoprost 0.005% QDTrabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks. | Drug | trabodenoson 6.0% /latanoprost 0.005% QD |
| trabodenoson 3.0% / latanoprost 0.005% QDTrabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks. | Drug | trabodenoson 3.0% /latanoprost 0.005% QD |
| trabodenoson 6.0% / latanoprost 0.0025% QDTrabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks. | Drug | trabodenoson 6.0% /latanoprost 0.0025%QD |
| latanoprost 0.005% QDLatanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks. | Drug | latanoprost 0.005% QD |
| latanoprost 0.0025% QDLatanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks. | Drug | latanoprost 0.0025% QD |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: Two Months
Daily change from diurnal baseline in IOP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 2 study testing trabodenoson 6.0% / latanoprost 0.005% QD, trabodenoson 3.0% / latanoprost 0.005% QD and trabodenoson 6.0% / latanoprost 0.0025% 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 15 Feb 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Two 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 15 Feb 2018.