Hypertension, Glaucoma, Open-AnglePhase 2NCT01493271
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
A Phase 2 study testing RO5093151 in people with Hypertension, Glaucoma, Open-Angle, run by Hoffmann-La Roche at 12 sites in 4 countries.
Trial summary
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, Glaucoma, Open-Angle
- What is being tested?
- RO5093151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Dec 2011to Nov 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, at least 21 years of age, inclusive
- Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
- Able to participate and willing to give informed consent
Who cannot join
- Presence of extreme narrow angle with complete or partial closure
- Progressive retinal or optic nerve disease from any cause other than glaucoma
- History or signs of penetrating ocular trauma
- Uncontrolled hypertension
- Clinically significant abnormalities in laboratory test results
- Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
- Kidney disease or dysfunction
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Czechia5 sites
Study site
Hradec Králové, 500 05
Study site
Litomysi, 570 14
Study site
Prague, 100 34
Study site
Ústí nad Labem, 401 13
Study site
Zlín, 762 75
United States3 sites
Study site
High Point, North Carolina, 27262
Study site
Morrow, Georgia, 30260
Study site
Mt. Pleasant, South Carolina, 29464
Hungary3 sites
Study site
Budapest, 1115
Study site
Budapest, 1125
Study site
Esztergom, 2500
About this study
Official title: An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.
- Conditions
- Hypertension, Glaucoma, Open-Angle
- Being tested
- Placebo, RO5093151
- Medical subject headings
- Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to RO5093151
RO5093151Drug
oral doses twice daily for up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RO5093151 | Experimental | Not described Receives: Drug: RO5093151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Measured: Day 7
Secondary outcomes (6)
Change in mean daily intraocular pressure (IOP)
Measured: Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Measured: Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
Measured: 7 days
Pharmacokinetics (area under the concentration time curve)
Measured: Day 7
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Measured: 7 days
Safety (incidence of adverse events)
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493271
- Sponsor's protocol ID
- BP25466
- Status last verified
- Nov 2016
- First submitted
- 14 Dec 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT01493271
- Acronym / sponsor ID
- BP25466
- Conditions
- Hypertension, Glaucoma, Open-Angle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Dec 2011 (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.
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| RO5093151 | Experimental | Drug: RO5093151 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, at least 21 years of age, inclusive
- Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
- Able to participate and willing to give informed consent
Key exclusion criteria (7 listed)
- Presence of extreme narrow angle with complete or partial closure
- Progressive retinal or optic nerve disease from any cause other than glaucoma
- History or signs of penetrating ocular trauma
- Uncontrolled hypertension
- Clinically significant abnormalities in laboratory test results
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 |
|---|---|---|
| PlaceboPlacebo to RO5093151 | Drug | Placebo |
| RO5093151oral doses twice daily for up to 28 days | Drug | RO5093151 |
Primary outcome
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Time frame: Day 7
6 secondary outcomes
Change in mean daily intraocular pressure (IOP)
Time frame: Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Time frame: Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
Time frame: 7 days
Pharmacokinetics (area under the concentration time curve)
Time frame: Day 7
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Time frame: 7 days
Safety (incidence of adverse events)
Time frame: Up to 28 days
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 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5093151 in people with Hypertension, Glaucoma, Open-Angle, run by Hoffmann-La Roche at 12 sites in 4 countries.
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 3 inclusion and 7 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Czechia, United States, Hungary, Bulgaria. 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 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?
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment (time frame: Day 7). 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 Nov 2016.