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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030288
Receipt No. R000034589
Scientific Title Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution to Timolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Date of disclosure of the study information 2017/12/07
Last modified on 2018/06/06

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Basic information
Public title Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution to Timolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Acronym Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Scientific Title Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution to Timolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazunori Miyata
Organization Miyata Eye Hospital
Division name Ophthalmology
Zip code
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
1st name
Middle name
Last name Satoru Kikuchi
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2017 Year 09 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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