Open Angle Glaucoma or Ocular Hypertension
Conditions
Brief 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. 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: 1. 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. 2. 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.
Interventions
one drop for each eye, once per day
DRUGOPC-1085EL
one drop for each eye, once per day
Sponsors
Otsuka Beijing Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Gender: Unlimited 2. Hospitalization status: Outpatients 3. Age: 20-80 years old 4. Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension. \[At the end of the screening period\] 5. 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.
Exclusion criteria
1. Subjects with a best-corrected visual acuity ≤ 0.2. 2. Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma. 3. Subjects who cannot stop using contact lenses during the trial. 4. Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy. 5. Subjects who are allergic to any ingredients in carteolol or latanoprost.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate pre-dose intraocular pressure change from baseline to week 8 | baseline；week 8 | Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraocular pressure | Week 4；Week 8: | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure |
| intraocular pressure change from baseline | Week 4；Week 8 | evaluate the effects of OPC-1085ELv.s.0.005% latanoprost by measure intraocular pressure |
| intraocular pressure change rate from baseline | week 4: | intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100% |
| Safety evaluation variable：adverse event | from screening period to evaluation period, assessed up to 3 weeks. | adverse event start date, end date, seriousness, severity, relationship to trial treatment (IMP causality), action taken with trial treatment, and outcome will be collect. |
Countries
China
Outcome results
None listed