Primary open-angle glaucoma (in the broad sense), ocular hypertension
Conditions
Interventions
Group A: (Stage 1) carteolol/latanoprost ophthalmic solution for 2 months. (Stage 2) timolol/latanoprost ophthalmic solution for 2 months
Group B: (Stage 1) timolol/latanoprost ophthalmic solution for
Sponsors
Miyata Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria for enrollment into the study. 1)Inpatient or outpatient: Outpatient 2)Age: 20 years or older (at the time of consent obtainment) 3)Patients who have been diagnosed with POAG (in the broad sense) or OH for both eyes at least 6 months before (at the time of consent obtainment) 4)Patients whose IOP in the eligibility examination is as follows: between 15 mmHg and 35 mmHg for one eye, less than 35 mmHg for the other eye, and within 5 mmHg of IOP differences between two eyes 5)Patients with prostaglandin ophthalmic solution, insufficient control of intraocular pressure
Exclusion criteria
Exclusion criteria: Patients are excluded from participation if any of the following criteria apply. For criteria relating to the eye, patients are excluded when one eye meets any of the criteria. 1)Patients with highest corrected visual acuity of 0.2 or lower 2)Patients who are not able to discontinue the use of contact lens during the evaluation period 3)Patients who have been administered the following drugs within 28 days before the initiation of the evaluation period: Beta blocker (instillation, systemic) Treatment drug for hypertension Corticosteroids (other than local dermal administration in sites other than the eyelid) Drugs with contraindications for glaucoma (anticholinergic agents such as scopolamine, mazindol, etc.) 4)Patients for whom new use or change of treatment drugs for glaucoma or OH (instillation or systemic, excluding the assigned study drug) is scheduled during the evaluation period 5)Patients with hypersensitivity to components of ophthalmic solution that contain carteolol hydrochloride, timolol maleate, or latanoprost and others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints Diurnal variation, maximum, minimum, and range of change of IOP Safety endpoints Vital signs (heart rate, blood pressure), fluorescein corneal staining score, bacteria test, ophthalmological subjective symptoms, adverse events | — |
Countries
Japan
Contacts
Public ContactSatoru Kikuchi
Otsuka Pharmaceutical Co., Ltd. Medical Affairs
Outcome results
None listed