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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002017
Receipt No. R000002460
Scientific Title Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Date of disclosure of the study information 2009/06/15
Last modified on 2012/06/02

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Basic information
Public title Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Acronym Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Scientific Title Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Scientific Title:Acronym Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of Taflurost and Latanoprost on intraocular pressure and safety in normal-tension glaucoma in randomized, open-labeled, crossover, study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy: Intraocular Pressure Lowering rate
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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tafluprost monotherapy of 12weeks, Latanoprost monotherapy of 12weeks and if possible, continue monotherapy with either ophthalmic solution for 52weeks
Interventions/Control_2 Latanoprost monotherapy of 12weeks, Tafluprost monotherapy of 12weeks and if possible, continue monotherapy with either ophthalmic solution for 52weeks.
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. Diagnosed with normal-tension glaucoma
2. Person whose agreement is shown by him/herself
3. Over 20 years old on the date of agreement.
4. Both male and female
5. Outpatient treatment
6. Having latanoprost monotherapy treatment more than 4 weeks and whose intraocular pressure is between 10 mmHg and 21 mmHg.
7. Over 0.1 of corrected visual acuity with an eye for evaluation.
8. If both eyes can be evaluated, an eye with higher intraocular pressure will be chosen for evaluation.
Key exclusion criteria 1. Severe visual field defect (Ex:HFA <-15dB)
2. Any corneal abnormality or other condition preventing reliable applanation tonometry.
3. Presence of any external ocular disease, inflammation or infection of the eye and/or eyelids.
4. History of refractive surgery.
5. Diagnosed with degenerative miopia
6. History of laser trabeculoplasty, filtering surgery, trabeculotomy, or cataract surgery within 6 months.
7. Presence of any hypersensitivity to test drugs.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Mori
Organization Kyoto Prefectural University of Medicine
Division name Department of ophthalmology
Zip code
Address Hirokoji Kawaramachi Kamigyo-ku Kyoto 602-0841
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Mori, Morio Ueno, Yoko Ikeda
Organization Kyoto Prefectural University of Medicine
Division name Department of ophthalmology
Zip code
Address
TEL 075-251-5578
Homepage URL
Email

Sponsor
Institute Department of ophthalmology, Kyoto Prefectural University of Medicine
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

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 Completed
Date of protocol fixation
2009 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 08 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 29 Day
Last modified on
2012 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002460

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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