UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000706 |
|---|---|
| Receipt number | R000000695 |
| Scientific Title | Efficacy of latanoprost (Xalatan) ophthalmic solution stored at room temperature |
| Date of disclosure of the study information | 2007/05/31 |
| Last modified on | 2009/03/24 17:56:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of latanoprost (Xalatan) ophthalmic solution stored at room temperature
Acronym
Latanoprost stored at room temperature
Scientific Title
Efficacy of latanoprost (Xalatan) ophthalmic solution stored at room temperature
Scientific Title:Acronym
Latanoprost stored at room temperature
Region
| Japan |
Condition
Condition
Glaucoma patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Xalatan is the most frequently used drug for the treatment of glaucoma. According to manifucturer's direction in Japan, it should be stored at 2 to 8 C. Becuse this storage condition is inconvinient for patients, we are going to evaluate efficacy of Xalatan stored in room temperature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra ocular pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
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
Xalatan ophthalmic solution stored at 4C applied once a day for 3 days.
Interventions/Control_2
Xalatan ophthalmic solution stored at 30 C applied once a day for 3 days.
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteers
Key exclusion criteria
abnormal findings in opthalmic examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiuchi, Yoshiaki |
Organization
Hiroshima University
Division name
Ophthalmology and Visual Science
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University
Division name
Ophthalmology and Visual Science
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University
Department of Ophthalmology and Visual Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2007 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2007 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 03 | Day |
Last modified on
| 2009 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000695
