Primary Open-angle GlaucomaPhase 1/2NCT01410188
Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing OPA-6566 and Latanoprost in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Kubota Vision Inc. at 9 sites in United States.
Trial summary
This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- OPA-6566 and Latanoprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bilateral primary open-angle glaucoma
- diagnosis of ocular hypertension as defined in the protocol
Who cannot join
- any form of glaucoma other than primary open-angle glaucoma in either eye
- other ocular conditions as defined by the protocol
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Artesia, California, 90701
Study site
Austin, Texas, 78731
Study site
Glendale, California, 91205
Study site
High Point, North Carolina, 27262
Study site
Louisville, Kentucky, 40217
Study site
Maryville, Tennessee, 37803
Study site
Roswell, Georgia, 30076
Study site
San Antonio, Texas, 78240
Study site
Washington, Missouri, 63090
About this study
Official title: An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Being tested
- OPA-6566, Placebo, Latanoprost
- Keywords
- open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure
- 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.
OPA-6566Drug
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
PlaceboDrug
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
LatanoprostDrug
Latanoprost (one drop once per day for 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| OPA-6566 low dose | Experimental | Treatment with OPA-6566 low dose Receives: Drug: OPA-6566 |
| OPA-6566 medium dose | Experimental | Treatment with OPA-6566 medium dose Receives: Drug: OPA-6566 |
| OPA-6566 high dose | Experimental | Treatment with OPA-6566 high dose Receives: Drug: OPA-6566 |
| Latanoprost | Active comparator | Treatment with Latanoprost Receives: Drug: Latanoprost |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| OPA-6566 additional dose | Experimental | Treatment with OPA-6566 additional dose Receives: Drug: OPA-6566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
Measured: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)
Secondary outcomes (2)
Composite of Pharmacokinetics
Measured: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
Efficacy: measurement of change in intraocular pressure from baseline.
Measured: 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- John W Chandler, MD, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410188
- Sponsor's protocol ID
- OPA-6566-101
- Status last verified
- Feb 2014
- First submitted
- 27 Jul 2011
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01410188
- Acronym / sponsor ID
- OPA-6566-101
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Aug 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 is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| OPA-6566 low dose | Experimental | Drug: OPA-6566Treatment with OPA-6566 low dose |
| OPA-6566 medium dose | Experimental | Drug: OPA-6566Treatment with OPA-6566 medium dose |
| OPA-6566 high dose | Experimental | Drug: OPA-6566Treatment with OPA-6566 high dose |
| Latanoprost | Active comparator | Drug: LatanoprostTreatment with Latanoprost |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| OPA-6566 additional dose | Experimental | Drug: OPA-6566Treatment with OPA-6566 additional dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of bilateral primary open-angle glaucoma
- diagnosis of ocular hypertension as defined in the protocol
Key exclusion criteria (2 listed)
- any form of glaucoma other than primary open-angle glaucoma in either eye
- other ocular conditions as defined by the protocol
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 |
|---|---|---|
| OPA-6566OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks) | Drug | OPA-6566 additional dose, OPA-6566 high dose, OPA-6566 low dose, OPA-6566 medium dose |
| PlaceboPlacebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks) | Drug | Placebo |
| LatanoprostLatanoprost (one drop once per day for 4 weeks) | Drug | Latanoprost |
Primary outcome
Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
Time frame: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)
2 secondary outcomes
Composite of Pharmacokinetics
Time frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
Efficacy: measurement of change in intraocular pressure from baseline.
Time frame: 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)
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 11 Mar 2014.
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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.
John W Chandler, MD study director
Kubota Vision Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OPA-6566 and Latanoprost in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Kubota Vision Inc. at 9 sites 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 2 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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine. (time frame: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)). 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 11 Mar 2014.