UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002021 |
|---|---|
| Receipt number | R000002467 |
| Scientific Title | A randomised crossover study comparing tafluprost and travoprost in subjects with normal tension glaucoma of pseudophakic eye |
| Date of disclosure of the study information | 2009/06/15 |
| Last modified on | 2009/05/31 06:20:48 |
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Basic information
Public title
A randomised crossover study comparing tafluprost and travoprost in subjects with normal tension glaucoma of pseudophakic eye
Acronym
The effect of tafluprost and travoprost in subjects with normal tension glaucoma of pseudophakic eye
Scientific Title
A randomised crossover study comparing tafluprost and travoprost in subjects with normal tension glaucoma of pseudophakic eye
Scientific Title:Acronym
The effect of tafluprost and travoprost in subjects with normal tension glaucoma of pseudophakic eye
Region
| Japan |
Condition
Condition
Normal tension glaucoma of pseudophakic eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tafluprost and travoprost on intraocular pressure and safety in subjects with normal tension glaucoma of pseudophakic eye in open-label, randomized crossover test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure reduction, % reduction of intraocular pressure
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Washout in treated with glaucoma medication for 1 month
Interventions/Control_2
Tafluprost or travoprost monotherapy 12 weeks treatment once a day
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; The patients with normal tension glaucoma of pseudophakic eye
2; Untreated or over 4 weeks washout in treated with glaucoma medications
Key exclusion criteria
1; Patients with exfoliation glaucoma and neovascular glaucoma
2; Patients with diabetic retinopathy
3; Excessive myopia before cataract surgery(>-6D)
4; Patients with advanced visual field loss(>-15dB)
5; Any corneal abnormality or other condition preventing reliable applanation tonometry
6; Presence of any external ocular disease, uveitis or infection of the eye and/or eye lid
7; History of refractive surgery
8; History of laser trabeculoplasty, filtering surgery, trabeculotomy and vitorectomy
9; Pregnant, pregnant suspect, and nursing woman. Woman who is wishing pregnancy or preventing pregnancy
10; The Investigator declare any subject ineligible for any sound medical reasion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori MIzoguchi |
Organization
MIzoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawaramachi Sasebo Nagasaki Japan 857-0016
TEL
0956-22-5681
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
MIzoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawaramachi Sasebo Nagasaki Japan 857-0016
TEL
0956-22-5681
Homepage URL
t-mizo@siren.ocn.ne.jp
Sponsor or person
Institute
MIzoguchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Non
Other related organizations
Co-sponsor
Non
Name of secondary funder(s)
Non
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
| 2009 | Year | 06 | Month | 15 | 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
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 31 | Day |
Last modified on
| 2009 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
