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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002021
Receipt No. 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

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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
Email

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
Email t-mizo@siren.ocn.ne.jp

Sponsor
Institute MIzoguchi Eye Clinic
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002467

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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