UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005062 |
|---|---|
| Receipt number | R000006022 |
| Scientific Title | Switching test from latanoprost to travoprost/timolol ophthalmic solution |
| Date of disclosure of the study information | 2011/02/13 |
| Last modified on | 2011/12/28 20:35:25 |
* 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
Switching test from latanoprost to travoprost/timolol ophthalmic solution
Acronym
Switching test to travoprost/timolol ophthalmic solution
Scientific Title
Switching test from latanoprost to travoprost/timolol ophthalmic solution
Scientific Title:Acronym
Switching test to travoprost/timolol ophthalmic solution
Region
| Japan |
Condition
Condition
Primary open angle glaucoma and ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing efficacy and safety of travoprost/timolol ophthalmic solution with latanoprost ophthalmic solution
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intra ocular pressure, blood pressure, pulse rate, corneal erosion, hyperemia
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
Swtiching from latanoprost ophthalmic solution to travoprost/timolol 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
Need anti-glaucoma therapy
Key exclusion criteria
active ocular diseases, severe heart and pulmonary diseases, history of allergy against employed ophthalmic solutions, less than six months after any incisional ocular surgery and ocluar trauma, and any other conditions that doctor recognizes inadequate for enrollment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Iijima |
Organization
University of Yamanashi
Division name
Ophthalmology
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Okudaira |
Organization
University of Yamanashi
Division name
Community and Family Medicine
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
Homepage URL
Sponsor or person
Institute
Association for Research in Supporting System of Chronic Diseases
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2011 | Year | 02 | Month | 13 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | 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
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006022
