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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006621
Receipt No. R000007833
Scientific Title Clinical evaluation of tafluprost and travoprost in Japanese patients with primary open angle glaucoma or ocular hypertension: multicenter, randomized, 12-week crossover study
Date of disclosure of the study information 2011/10/30
Last modified on 2019/08/05

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Basic information
Public title Clinical evaluation of tafluprost and travoprost in Japanese patients with primary open angle glaucoma or ocular hypertension: multicenter, randomized, 12-week crossover study
Acronym Clinical evaluation of tafluprost and travoprost in glaucoma patients
Scientific Title Clinical evaluation of tafluprost and travoprost in Japanese patients with primary open angle glaucoma or ocular hypertension: multicenter, randomized, 12-week crossover study
Scientific Title:Acronym Clinical evaluation of tafluprost and travoprost in glaucoma patients
Region
Japan

Condition
Condition Primary open angle glaucoma or ocular hypertension
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare ocular surface safety and intraocular pressure-lowering effect between tafluprost and travoprost in multicenter, randomized, crossover study,
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Corneal fluorescein staining scores
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 Subjects are treated with tafluprost ophthalmic solution once daily for 12 week
Interventions/Control_2 Subjects are treated with travoprost ophthalmic solution once daily for 12 week
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. Patients who diagnosed with primary open angle glaucoma or ocular hypertension in one eye or both eyes.
2. Patients who has been treated with prostaglandin analogue, adrenergic antagonist or both over 12 weeks or those who is newly diagnosed with primary open angle glaucoma or ocular hypertension.
3. Regardless of sex.
4. Aged 20 years or more.
5. Outpatients.
6. Have provided a written informed consent.
7. In unilateral patient, the affected eye is evaluation eye. In case of bilateral patinet, right eye is evaluation eye.
Key exclusion criteria 1. Patinets who with a history of allergy (i.e. hypersensitivity) to the drugs to be used during the study period.
2. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential.
3. Patients who with a history of corneal refractive surgery.
4. Patinets who need wearing contact lenses during the study period.
5. Patinets who with extraocular disease, inflammation or infection in the eye(s) or eyelid(s).
6. Patinets who with a history of cataract surgery within 12 months.
7. Patinets who with a history of intraocular surgery including ocular laser treatment against glaucoma within 12 months
8. Patinets who has been treated with prostaglandin/timolol malate fixed combination.
9. Patinets who has been treated with prostaglandin generic drug.
10. Patinets who is treated dry eye therapy (drug medication, punctum plug and punctum occlusion).
11. Patinets who the investigator consider ineligible for enrolment
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University
Division name Ophthalmology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Ophthalmology
Zip code
Address
TEL 082-257-5555
Homepage URL
Email

Sponsor
Institute Hiroshima uiversity
Institute
Department

Funding Source
Organization Hiroshima uiversity
Organization
Division
Category of Funding Organization
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
2011 Year 10 Month 30 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
2011 Year 07 Month 05 Day
Date of IRB
2011 Year 07 Month 27 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 27 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007833

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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