UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016465 |
|---|---|
| Receipt number | R000017614 |
| Scientific Title | Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2017/08/03 21:42:23 |
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Basic information
Public title
Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Acronym
Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Scientific Title
Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Scientific Title:Acronym
Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Region
| Japan |
Condition
Condition
primary open angle glaucoma or ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and efficacy of TAPCOM combination ophthalmic solution (tafluprost/timolole maleate ophthalmic solution) switched from Xalatan Ophthalmic Solution 0.005% (latanoprost ophthalmic solution 0.005%) in patients with primary open angle glaucoma or ocular hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of intraocular pressure
Topical and systemic adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
switch Xalatan Ophthalmic Solution to TAPCOM Combination Ophthalmic Solution
Interventions/Control_2
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 whose IOP control with the monotherapy of Xalatan is considered insufficient by the investigator and patients with primary open angle glaucoma or ocular hypertension
Patients who can submit informed consent in writing and visit the hospital according to the observation/test schedule determined in the study protocol
Key exclusion criteria
Patients with allergy to the ingredients used in the present study
Patients who are contraindicated to Beta blockers
Patients who the investigator consider ineligible for enrollment
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kiuchi |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
ykiuchi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Okumichi |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
Homepage URL
okumic@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Santen 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
広島大学病院（広島県）hiroshima University Hospital (Hiroshima Pref.)
白井病院（香川県） Shirai Eye Hospital (Kagawa Pref.)
広島記念病院（広島県） Hiroshima Memorial Hospital (Hiroshima Pref.)
金光病院（岡山県） Konko Hospital (Okayama Pref.)
ツカザキ病院（兵庫県） Tsukazaki Hospital (Hyogo Pref.)
広島総合病院（広島県） Hiroshima General Hospital (Hiroshima Pref.)
県立広島病院（広島県） Hiroshima Prefectural Hospital (Hiroshima Pref.)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=33383
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | 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
| 2015 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017614
