Ocular Hypertension (OHT)Phase 1NCT01670266
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
A Phase 1 study testing ONO-9054 in people with Ocular Hypertension (OHT) and Mild Open Angle-glaucoma (OAG), run by Ono Pharma USA Inc at 3 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ocular Hypertension (OHT), Mild Open Angle-glaucoma (OAG)
- What is being tested?
- ONO-9054
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to May 2013
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG
- Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma
- Able to undergo washout of all ocular drugs
- An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1
- Central corneal thickness 500-600 µm at screening in both eyes
- BCVA 20/100 or better in both eyes
Who cannot join
- Any history of severe ocular trauma in either eye at any time
- Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of screening visit in the study eye(s)
- Cataracts that prevent observation of the fundus in either eye
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Costa Mesa Clinical Site
Costa Mesa, California, 92626
Newport Beach (satellite site)
Newport Beach, California, 92663
Santa Ana (satellite site)
Santa Ana, California, 92705
About this study
Official title: A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma
The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG).
The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.
- Being tested
- ONO-9054, Placebo
- Keywords
- ONO-9054, ocular hypertension, OHT, Open angle-glaucoma, OAG, Glaucoma, Eye diseases
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-9054Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1 | Experimental | Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18 Receives: Drug: ONO-9054 |
| Experimental Arm 2 | Experimental | Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18 Receives: Drug: ONO-9054 |
| Experimental Arm 3 | Experimental | Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18 Receives: Drug: ONO-9054 |
| Experimental Arm 4 | Experimental | Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo Receives: Drug: ONO-9054; Drug: Placebo |
| Placebo Arm | Placebo comparator | Matched placebo eye drops dosed in same manner as ONO-9054 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ONO-9054
Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
Measured: up to 14 days
Secondary outcomes (3)
Characterization of PK profiles
The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days
Measured: up to 14 days
Evaluation of PD measurements
The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.
Measured: up to 14 days
Comparison of safety, tolerability between once daily morning and once daily evening
Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Hypertension (OHT)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670266
- Sponsor's protocol ID
- ONO-9054IOU002
- Status last verified
- May 2013
- First submitted
- 15 Aug 2012
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9.
PubMed 26453641
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01670266
- Acronym / sponsor ID
- ONO-9054IOU002
- Keywords
- ONO-9054, ocular hypertension, OHT, Open angle-glaucoma, OAG, Glaucoma, Eye diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- First posted
- 22 Aug 2012 (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 primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG).
The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1 | Experimental | Drug: ONO-9054Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18 |
| Experimental Arm 2 | Experimental | Drug: ONO-9054Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18 |
| Experimental Arm 3 | Experimental | Drug: ONO-9054Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18 |
| Experimental Arm 4 | Experimental | Drug: ONO-9054, Drug: PlaceboExperimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo |
| Placebo Arm | Placebo comparator | Drug: PlaceboMatched placebo eye drops dosed in same manner as ONO-9054 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG
- Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma
- Able to undergo washout of all ocular drugs
- An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1
- Central corneal thickness 500-600 µm at screening in both eyes
Key exclusion criteria (3 listed)
- Any history of severe ocular trauma in either eye at any time
- Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of screening visit in the study eye(s)
- Cataracts that prevent observation of the fundus in either eye
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 |
|---|---|---|
| ONO-9054 | Drug | Experimental Arm 1, Experimental Arm 2, Experimental Arm 3, Experimental Arm 4 |
| Placebo | Drug | Experimental Arm 4, Placebo Arm |
Primary outcome
Safety and tolerability of ONO-9054
Time frame: up to 14 days
Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
3 secondary outcomes
Characterization of PK profiles
Time frame: up to 14 days
Evaluation of PD measurements
Time frame: up to 14 days
Comparison of safety, tolerability between once daily morning and once daily evening
Time frame: 14 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 3 Jun 2013.
- Derived from this study: PubMed 26453641Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9.
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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.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-9054 in people with Ocular Hypertension (OHT) and Mild Open Angle-glaucoma (OAG), run by Ono Pharma USA Inc at 3 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 6 inclusion and 3 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 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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 and tolerability of ONO-9054 (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670266, which also lists 1 linked publication.
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 3 Jun 2013.