UMIN-CTR Clinical Trial

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