Open Angle Glaucoma or Ocular HypertensionPhase 3NCT05583474
OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
A Phase 3 study testing OPC-1085EL and 0.005% Latanoprost in people with Open Angle Glaucoma or Ocular Hypertension, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Open Angle Glaucoma or Ocular Hypertension
- What is being tested?
- OPC-1085EL and 0.005% Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to 26 Dec 2024
- Phase
- Phase 3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Unlimited
- Hospitalization status: Outpatients
- Age: 20-80 years old
- Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension.
- [At the end of the screening period]
- IOP: After 4 weeks treatment with 0.005% latanoprost, the unilateral eye with a pre-dose IOP from 18 mmHg to <30 mmHg, and IOP <30 mmHg in the contralateral eye.
Who cannot join
- Subjects with a best-corrected visual acuity ≤ 0.2.
- Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
- Subjects who cannot stop using contact lenses during the trial.
- Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
- Subjects who are allergic to any ingredients in carteolol or latanoprost.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multi-center, Randomized, Single-blind (to Evaluator), Parallel, and Positive-controlled Clinical Trial Evaluating the Efficacy and Safety of OPC-1085EL Ophthalmic Solution in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.
Read the detailed description
The trial includes 2 period:
- Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day.
- Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day.
- Being tested
- OPC-1085EL, 0.005% Latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-1085ELDrug
Also called OPC-1085EL ophthalmic solution
one drop for each eye, once per day
0.005% LatanoprostDrug
Also called 0.005% Latanoprost ophthalmic solution
one drop for each eye, once per day
| Study group | Role | What they receive |
|---|---|---|
| subject receive OPC-1085EL solution | Experimental | OPC-1085EL group ，one drop for each eye, once per day for 8 weeks Receives: Drug: OPC-1085EL |
| subject receive 0.005% latanoprost ophthalmic solution | Active comparator | 0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks Receives: Drug: 0.005% Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate pre-dose intraocular pressure change from baseline to week 8
Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured
Measured: baseline；week 8
Secondary outcomes (4)
intraocular pressure
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
Measured: Week 4；Week 8:
intraocular pressure change from baseline
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure
Measured: Week 4；Week 8
intraocular pressure change rate from baseline
intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%
Measured: week 4:
Safety evaluation variable：adverse event
adverse event start date, end date, seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect.
Measured: from screening period to evaluation period, assessed up to 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start27 Sep 2022
- Primary completion22 Nov 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma or Ocular HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huaixing Sun, Doctor, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583474
- Sponsor's protocol ID
- 001-403-00013
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center, Randomized, Single-blind (to Evaluator), Parallel, and Positive-controlled Clinical Trial Evaluating the Efficacy and Safety of OPC-1085EL Ophthalmic Solution in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
- ClinicalTrials.gov ID
- NCT05583474
- Acronym / sponsor ID
- 001-403-00013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- 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.
It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.
Detailed description
The trial includes 2 period:
- Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day.
- Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subject receive OPC-1085EL solution | Experimental | Drug: OPC-1085ELOPC-1085EL group ，one drop for each eye, once per day for 8 weeks |
| subject receive 0.005% latanoprost ophthalmic solution | Active comparator | Drug: 0.005% Latanoprost0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: Unlimited
- Hospitalization status: Outpatients
- Age: 20-80 years old
- Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension.
- [At the end of the screening period]
Key exclusion criteria (5 listed)
- Subjects with a best-corrected visual acuity ≤ 0.2.
- Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
- Subjects who cannot stop using contact lenses during the trial.
- Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
- Subjects who are allergic to any ingredients in carteolol or latanoprost.
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-1085ELAlso: OPC-1085EL ophthalmic solutionone drop for each eye, once per day | Drug | subject receive OPC-1085EL solution |
| 0.005% LatanoprostAlso: 0.005% Latanoprost ophthalmic solutionone drop for each eye, once per day | Drug | subject receive 0.005% latanoprost ophthalmic solution |
Primary outcome
evaluate pre-dose intraocular pressure change from baseline to week 8
Time frame: baseline；week 8
Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured
4 secondary outcomes
intraocular pressure
Time frame: Week 4；Week 8:
intraocular pressure change from baseline
Time frame: Week 4；Week 8
intraocular pressure change rate from baseline
Time frame: week 4:
Safety evaluation variable：adverse event
Time frame: from screening period to evaluation period, assessed up to 3 weeks.
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 27 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Huaixing Sun, Doctor principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPC-1085EL and 0.005% Latanoprost in people with Open Angle Glaucoma or Ocular Hypertension, run by Otsuka Beijing Research Institute at 1 site in China.
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 5 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 27 Mar 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
evaluate pre-dose intraocular pressure change from baseline to week 8 (time frame: baseline；week 8). 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 27 Mar 2025.