NCT05583474CompletedPhase 3
OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 8 Oct 2022
- Start date
- 27 Sept 2022
- Primary completion date
- 22 Nov 2024
- Lead sponsor
- Otsuka Beijing Research Institute
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT05583474
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 204
- From 27 Sept 2022 to the primary completion date, 22 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
Other illness
- Subjects who are allergic to any ingredients in carteolol or latanoprost.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eye ENT Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.