UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002915 |
|---|---|
| Receipt number | R000003553 |
| Scientific Title | Effects of tafluprost and latanoprost on ocular blood flow and visual field |
| Date of disclosure of the study information | 2009/12/25 |
| Last modified on | 2013/06/17 19:16:45 |
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Basic information
Public title
Effects of tafluprost and latanoprost on ocular blood flow and visual field
Acronym
Effects of tafluprost and latanoprost on ocular blood flow and visual field
Scientific Title
Effects of tafluprost and latanoprost on ocular blood flow and visual field
Scientific Title:Acronym
Effects of tafluprost and latanoprost on ocular blood flow and visual field
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tafluprost and latanoprost on intraocular pressure, ocular blood flow and visual field
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Tafluprost group: 3-year treatment once daily
Interventions/Control_2
Latanoprost group: 3-year treatment once daily
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
1) At least one eye is POAG, the other eye can be under the same treatment or untreated during study period. 2) 20 or older than 20. 3) Both sexes. 4) Outpatient. 5) Provided signed, written informed consent. 6) Patients who can follow designated examination and observation. 7) IOPs of both eyes after washout are 25 mmHg or under 25 mmHg. 8) Patients who are untreated or completed designated washout.
Key exclusion criteria
1)Patients with eye diseases except for glaucoma or mild cataract. 2) Patients with progressing and/or advanced glaucoma. 3) Patients with any corneal abnormality or other condition preventing reliable applanation tonometry. 4) Patients with active external ocular diseases, ocular inflammation or infection. 5) Patients with history of refractive surgery. 6)Patients with history of intraocular surgery within 6 months. 7) Smokers. 8) Patients who will use restricted medicines. 9) Patients whose ocular blood flow is unable to measure. 10) Patients whom investigators declare ineligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Sugiyama |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
Address
2-7 Daigaku-machi, Takatsuki-shi, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
Address
TEL
072-683-1221
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Osaka Medical College
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
大阪医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 25 | 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
| 2009 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 17 | Day |
Last modified on
| 2013 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003553
