Ocular HypertensionPhase 2NCT02083289
A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
A Phase 2 study testing ONO-9054 and Latanoprost in people with Ocular Hypertension and Open Angle-glaucoma, run by Ono Pharmaceutical Co., Ltd. at 12 sites in United States.
Trial summary
The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ocular Hypertension, Open Angle-glaucoma
- What is being tested?
- ONO-9054 and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2014to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG
- Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
- Able to undergo washout of all ocular drugs
- An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36 mmHg in both eyes at both Day -5 and Day 1
- Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
- Best corrected visual acuity (BCVA) of +0.7 Log Mar or better
Who cannot join
- Any history of severe ocular trauma in either eye at any time
- History of angle closure 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 or photography of the fundus in either eye
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Austin Clinical Site
Austin, Texas, 78731
Cranberry Township Clinical Site
Cranberry Township, Pennsylvania, 16066
High Point Clinical Site
High Point, North Carolina, 27262
Los Angeles Clinical Site
Los Angeles, California, 90048
Mission Hills Clinical Site
Mission Hills, California, 91345
Morrow Clinical Site
Morrow, Georgia, 30260
New York Clinical Site
New York, New York, 10029
Newport Beach Clinical Site
Newport Beach, California, 92663
Pasadena Clinical Site
Pasadena, California, 91105
Petaluma Clinical Site
Petaluma, California, 94954
Philadelphia Clinical Site
Philadelphia, Pennsylvania, 19104
Roswell Clinical Site
Roswell, Georgia, 30076
About this study
Official title: A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days.
- Conditions
- Ocular Hypertension, Open Angle-glaucoma
- Being tested
- ONO-9054, Latanoprost
- Keywords
- ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate
- 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
LatanoprostDrug
Also called Xalatan®
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1 | Experimental | ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days. Receives: Drug: ONO-9054 |
| Active Comparator Arm 2 | Active comparator | Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days. Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in diurnal IOP (average of four time points) from baseline
Measured: 28 days
Evaluating the safety parameters per protocol
Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
Measured: 28 days
Secondary outcomes (4)
Diurnal IOP
Measured: 28 days
Mean change from baseline in IOP at each measured time point
Measured: 28 days
Treatment response rates
Measured: 28 days
Percent change from baseline in IOP at each measured time point
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Ono 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharmaceutical Co., Ltd., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083289
- Sponsor's protocol ID
- ONO-9054IOU003
- Status last verified
- Jan 2016
- First submitted
- 6 Mar 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.
PubMed 27649982
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT02083289
- Acronym / sponsor ID
- ONO-9054IOU003
- Conditions
- Ocular Hypertension, Open Angle-glaucoma
- Keywords
- ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2014 (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 objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 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 |
|---|---|---|
| Experimental Arm 1 | Experimental | Drug: ONO-9054ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days. |
| Active Comparator Arm 2 | Active comparator | Drug: LatanoprostLatanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG
- Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
- Able to undergo washout of all ocular drugs
- An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36 mmHg in both eyes at both Day -5 and Day 1
- Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
Key exclusion criteria (3 listed)
- Any history of severe ocular trauma in either eye at any time
- History of angle closure 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 or photography 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 |
| LatanoprostAlso: Xalatan® | Drug | Active Comparator Arm 2 |
Primary outcome
Mean change in diurnal IOP (average of four time points) from baseline
Time frame: 28 days
Evaluating the safety parameters per protocol
Time frame: 28 days
Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
4 secondary outcomes
Diurnal IOP
Time frame: 28 days
Mean change from baseline in IOP at each measured time point
Time frame: 28 days
Treatment response rates
Time frame: 28 days
Percent change from baseline in IOP at each measured time point
Time frame: 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 25 Feb 2016.
- Derived from this study: PubMed 27649982Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.
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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 Pharmaceutical Co., Ltd. study director
Ono Pharmaceutical Co., Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-9054 and Latanoprost in people with Ocular Hypertension and Open Angle-glaucoma, run by Ono Pharmaceutical Co., Ltd. at 12 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 25 Feb 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 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?
Mean change in diurnal IOP (average of four time points) from baseline (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT02083289, 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 25 Feb 2016.