UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006621 |
|---|---|
| Receipt number | 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 19:15:02 |
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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
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
Sponsor or person
Institute
Hiroshima uiversity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007833
