UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution to Timolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Title of the study (Brief title)	Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Region	Japan

Condition
Condition	Primary open-angle glaucoma (in the broad sense), ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of the night instillation of carteolol/latanoprost combination ophthalmic solution in patients with glaucoma on the diurnal variations of IOP and on the circulatory system in comparison with timolol/latanoprost combination ophthalmic solution
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: (Stage 1) carteolol/latanoprost ophthalmic solution for 2 months. (Stage 2) timolol/latanoprost ophthalmic solution for 2 months
Interventions/Control_2	Group B: (Stage 1) timolol/latanoprost ophthalmic solution for 2 months. (Stage 2) carteolol/latanoprost ophthalmic solution for 2 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	15

Research contact person
Name of lead principal investigator	Kazunori Miyata
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Address	6-3 Kurahara-cho, Miyakonojyo-shi, Miyazaki pref.
TEL	0986-22-1441
Email	maruyama@miyata-med.ne.jp

Public contact
Name of contact person	Satoru Kikuchi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs
Address	2-16-4 Konan, Minato-ku, Tokyo, Japan
TEL	03-6361-7337
Homepage URL
Email	kikuchis@otsuka.jp

Sponsor
Institute	Miyata Eye Hospital
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 09 Month 22 Day
Anticipated trial start date	2017 Year 11 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 06 Day
Last modified on	2018 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034589