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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002915
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, Osaka Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003553

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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