UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030288 |
|---|---|
| Receipt number | 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 14:27:56 |
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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
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
kikuchis@otsuka.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034589
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