GlaucomaPhase 1NCT02108288
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
A Phase 1 study testing OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution and Latanoprost ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution and Latanoprost ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2014to Aug 2014
- Phase
- Phase 1
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are considered medically healthy per investigator's judgment
Who cannot join
- Subjects with ocular conditions as defined by the protocol
- Subjects with intraocular pressure: <10 or ≥22 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution, Latanoprost ophthalmic solution
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-1085EL ophthalmic solutionDrug
Carteolol long-acting ophthalmic solutionDrug
Latanoprost ophthalmic solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| OPC-1085EL ophthalmic solution | Experimental | Once daily Receives: Drug: OPC-1085EL ophthalmic solution |
| Carteolol long-acting ophthalmic solution | Active comparator | Once daily Receives: Drug: Carteolol long-acting ophthalmic solution |
| Latanoprost ophthalmic solution | Active comparator | Once daily Receives: Drug: Latanoprost ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Carteolol
Measured: Day 1 and Day 7
Cmax of Latanoprost Acid
Measured: Day 1 and Day 7
Secondary outcomes (2)
Tmax of Carteolol
Measured: Day 1 and Day 7
Tmax of Latanoprost Acid
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionAug 2014
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 GlaucomaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108288
- Sponsor's protocol ID
- 1085EL-13-004
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2014
- Last updated
- 22 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
- ClinicalTrials.gov ID
- NCT02108288
- Acronym / sponsor ID
- 1085EL-13-004
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPC-1085EL ophthalmic solution | Experimental | Drug: OPC-1085EL ophthalmic solutionOnce daily |
| Carteolol long-acting ophthalmic solution | Active comparator | Drug: Carteolol long-acting ophthalmic solutionOnce daily |
| Latanoprost ophthalmic solution | Active comparator | Drug: Latanoprost ophthalmic solutionOnce daily |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who are considered medically healthy per investigator's judgment
Key exclusion criteria (2 listed)
- Subjects with ocular conditions as defined by the protocol
- Subjects with intraocular pressure: <10 or ≥22 mmHg
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 |
|---|---|---|
| OPC-1085EL ophthalmic solution | Drug | OPC-1085EL ophthalmic solution |
| Carteolol long-acting ophthalmic solution | Drug | Carteolol long-acting ophthalmic solution |
| Latanoprost ophthalmic solution | Drug | Latanoprost ophthalmic solution |
Primary outcome
Cmax of Carteolol
Time frame: Day 1 and Day 7
Cmax of Latanoprost Acid
Time frame: Day 1 and Day 7
2 secondary outcomes
Tmax of Carteolol
Time frame: Day 1 and Day 7
Tmax of Latanoprost Acid
Time frame: Day 1 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1 study testing OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution and Latanoprost ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 1 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 22 Apr 2015. 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 Japan. 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 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.
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 2 Apr 2015). 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?
Cmax of Carteolol (time frame: Day 1 and Day 7). The study lists 2 primary outcomes in all. 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 22 Apr 2015.