Primary Open-Angle Glaucoma (POAG)Phase 2NCT01917383
A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
A Phase 2 study testing Trabodenoson, Latanoprost and Timolol 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
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… 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, Latanoprost and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2014
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Being tested
- Trabodenoson, Latanoprost, Timolol
- 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.
TrabodenosonDrug
Also called INO-8875
Ophthalmic eye drop
LatanoprostDrug
Also called Xalatan
Ophthalmic eye drop
TimololDrug
Also called Timoptic
Ophthalmic eye drop
| Study group | Role | What they receive |
|---|---|---|
| Trabodenoson Plus Latanoprost | Experimental | Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop Receives: Drug: Trabodenoson; Drug: Latanoprost |
| Timolol Plus Latanoprost | Active comparator | A Beta-blocker eye drop plus a prostaglandin analogue eye drop Receives: Drug: Latanoprost; Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionSep 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotek Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917383
- Sponsor's protocol ID
- IPC-01-2013
- Status last verified
- Nov 2017
- First submitted
- 5 Aug 2013
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01917383
- Acronym / sponsor ID
- IPC-01-2013
- 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
- 101 participants (actual)
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Aug 2013 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabodenoson Plus Latanoprost | Experimental | Drug: Trabodenoson, Drug: LatanoprostExperimental ophthalmic eye drop plus a prostaglandin analogue eye drop |
| Timolol Plus Latanoprost | Active comparator | Drug: Latanoprost, Drug: TimololA Beta-blocker eye drop plus a prostaglandin analogue eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| TrabodenosonAlso: INO-8875Ophthalmic eye drop | Drug | Trabodenoson Plus Latanoprost |
| LatanoprostAlso: XalatanOphthalmic eye drop | Drug | Timolol Plus Latanoprost, Trabodenoson Plus Latanoprost |
| TimololAlso: TimopticOphthalmic eye drop | Drug | Timolol Plus Latanoprost |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 12 weeks
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 2 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Latanoprost and Timolol 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 4 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 2 Dec 2017. 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?
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?
Intraocular Pressure (IOP) (time frame: 12 weeks). 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 2 Dec 2017.