OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: subject receive OPC-1085EL solution OPC-1085EL group ，one drop for each eye, once per day for 8 weeks |
Drug: OPC-1085EL
one drop for each eye, once per day
Other Names:
|
| Active Comparator: subject receive 0.005% latanoprost ophthalmic solution 0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks |
Drug: 0.005% Latanoprost
one drop for each eye, once per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- to evaluate the pre-dose intraocular pressure change from baseline to week 8 of the study eye. [baseline: pre-dose intraocular pressure at the end of screening period；week 8: pre-dose intraocular pressure.]
The study eye was defined as the eye with higher pre-dose intraocular pressure at the end of the screening period, or the right eye if the intraocular pressure values of both eyes were equal. Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured at the end of screening period are defined as the baseline intraocular pressure of the subject for each corresponding time point.
Secondary Outcome Measures
- intraocular pressure [Week 4: Pre-dose ；Week 8: Pre-dose, 2 hours after dosing]
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost in Chinese subjects with primary open angle glaucoma or ocular hypertension in intraocular pressure
- intraocular pressure change from baseline [Week 4: Pre-dose；Week 8: 2 hours after dosing]
evaluate the effects of OPC-1085ELv.s.0.005% latanoprost in Chinese subjects with primary open angle glaucoma or ocular hypertension in intraocular pressure
- intraocular pressure change rate from baseline [Week 4: Pre-dose；Week 8:Pre-dose, 2 hours after dosing]
intraocular pressure change rate=(intraocular pressure change from baseline at each time point)/ (corresponding baseline intraocular pressure) × 100%
- Proportions of subjects achieving the intraocular pressures ≤ 18 mmHg, ≤16 mmHg, or ≤ 14 mmHg. [Week 8: Pre-dose, 2 hours after dosing]
evaluate the intraocular pressure lowering effects of OPC-1085ELv.s.0.005% latanoprost in Chinese subjects with primary open angle glaucoma or ocular hypertension.
- Proportions of subjects achieving the intraocular pressure reduction ≥ 2 mmHg, ≥4 mmHg, or ≥6 mmHg. [Week 8: Pre-dose, 2 hours after dosing]
evaluate the intraocular pressure lowering effects of OPC-1085ELv.s.0.005% latanoprost in Chinese subjects with primary open angle glaucoma or ocular hypertension.
- Proportions of subjects achieving the intraocular pressure reduction rate ≥10%, ≥ 20%,or ≥30%. [Week 8: Pre-dose, 2 hours after dosing]
evaluate the intraocular pressure lowering effects of OPC-1085ELv.s.0.005% latanoprost in Chinese subjects with primary open angle glaucoma or ocular hypertension.
- 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.
- Safety evaluation variable：examination of visual acuity [screening, pre-dose at the end of screening period; week 8: 2 hours after dosing.]
measure the best corrected visual acuity of both eyes by using visual testing chart , record the measurement results (decimal visual acuity).
- Safety evaluation variable：subjective symptoms of eyes [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
using ocular conscious symptoms questionnaire collect the subjective symptoms of the left and right eyes
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the eyelids edema [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if eyelids has edema, pigmentation, hairy and depression.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the palpebral conjunctiva [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if palpebral conjunctiva has edema, hyperemia.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the bulbar conjunctiva [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if bulbar conjunctiva has edema, hyperemia.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the eyelid margin. [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if eyelid margin has edema, hyperemia and eyelash abnormalities.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the cornea. [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if cornea has edema, epithelial injury.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the iris. [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if iris has anterior or posterior adhesion, pigmentation.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the anterior chamber. [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if anterior chamber has cells or turbidity.
- Safety evaluation variable：binoculus with naked eye or slit-lamp microscope (non-mydriatic) abserve conditions of the lens. [screening, pre-dose at 2 week of screening period; pre-dose at the end of screening period; Week 4: Pre-dose; week 8: 2 hours after dosing.]
if luns has turbidity.
- Safety evaluation variable：fundus examination [screening; pre-dose at the end of screening period; week 8: 2 hours after dosing.]
Conditions of the retina, vitreous body, optic nerve and papilla of optic nerve in both eyes are evaluated under non-mydriatic conditions
- Safety evaluation variable：size of glaucoma visual field loss and central visual field loss [screening or data within 6 months prior to obtaining informed consent can be used]
evaluate if has glaucoma visual field loss and central visual field loss in both eyes by perimetry.
- Safety evaluation variable：gonioscopy [screening or data within 6 months prior to obtaining informed consent can be used]
Shaffer classification evaluation is conducted on both eyes, Grade 0: Complete or partial closure of the chamber angle; Grade 1: severe narrow chamber angle; Grade 2: mild narrow chamber angle; Grade 3-4: Broad chamber angle
- Safety evaluation variable：comfort in the use of investigational medicinal product (IMP) [Week 4: Pre-dose; week 8: 2 hours after dosing.]
doctors through inquiry evaluated the degree of comfort, according to the following criteria: 0: Not uncomfortable at all in use. 1: Slightly uncomfortable in use, but it is not a big problem. 2: Uncomfortable in use, but it is tolerable. 3: Very uncomfortable in use, and it is intolerable.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Gender: Unlimited
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Hospitalization status: Outpatients
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Age: 20-80 years old
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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.
Exclusion Criteria:
-
Subjects with a best-corrected visual acuity ≤ 0.2.
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Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
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Subjects who cannot stop using contact lenses during the trial.
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Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
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Subjects who are allergic to any ingredients in carteolol or latanoprost.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye & ENT Hospital of Fudan University | Shanghai | China |
Sponsors and Collaborators
- Otsuka Beijing Research Institute
Investigators
- Principal Investigator: Huaixing Sun, Doctor, Eye & ENT Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 001-403-00013