UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of tafluprost and latanoprost on progression of visual field loss in primary open angle glaucoma: prospective, randomized, open, multi-center study.
Acronym	Comparison of tafluprost and latanoprost on progression of visual field loss in primary open angle glaucoma
Scientific Title	Comparison of tafluprost and latanoprost on progression of visual field loss in primary open angle glaucoma: prospective, randomized, open, multi-center study.
Scientific Title:Acronym	Comparison of tafluprost and latanoprost on progression of visual field loss in primary open angle glaucoma
Region	Japan

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

Objectives
Narrative objectives1	To compare the effects of tafluprost and latanoprost on progression of visual field loss in patients with primary open angle glaucoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of visual field parameters
Key secondary outcomes	Change of intraocular pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The subjects are instilled the 0.0015% tafluprost ophthalmic solution once a day for 36 months. The subjects are visited a hospital at every 3 month intervals and measured intraocular pressure and examined anterior segments of the eye. Visual field is measured at every 6 months interval after treatment of medicine.
Interventions/Control_2	The subjects are instilled the 0.005% latanoprost ophthalmic solution once a day for 36 months. The subjects are visited a hospital at every 3 month intervals and measured intraocular pressure and examined anterior segments of the eye. Visual field is measured at every 6 months interval after treatment of medicine.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with 0.005% latanoprost monotherapy over 3 months at time when obtain a patient's consent. 2. Diagnosed patients with glaucomatous visual field loss at least one eye. Patients with MD value between -20 dB to -3 dB. 3. Patients with diurnal IOP less than or equal to 19 mmHg. 4. Diagnosed patients with open angle as Grade 3 or 4 of Shaffer's classification
Key exclusion criteria	1. Patients had not reliable visual field measurements (fixation loss of less than 20%, and a false-negative rate and a false-positive rate of less than 33%) 2. Any corneal abnormality or other condition preventing reliable applanation tonometry. 3. Require concomitant IOP-lowering medication or glaucoma surgery 4. Refractive error in spherical equivalent exceed -8D or +8D. 5. Patient under treatment with steroids. 6. History of cataracta surgery within 6 months before start of study. 7. History of glaucoma surgery including laser iridectomy and trabeculoplasty. 8. Presence of any active external ocular disease, inflammation or infection of the eye and/or eyelids. 9. Presence of ocular disease preventing reliable visual field measurements.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Yoshitomi, MD
Organization	Akita Graduate University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	1-1-1, Hondou, Akita
TEL	018-834-1111
Email

Public contact
Name of contact person	1st name Middle name Last name Makoto Ishikawa
Organization	Akita University, School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	Hondo 1-1-1, Akita 010-8543
TEL	018-834-1111
Homepage URL
Email	michinok@med.akita-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Akita Univ. School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	山形大学医学部附属病院眼科(山形県) Yamagata Univ. School of Medicine 岩手医科大学附属病院眼科(岩手県) Iwate Medical Univ. 弘前大学医学部附属病院眼科(青森県) Hirosaki Univ. School of Medicine おのば眼科医院(秋田県) Onoba Eye Clinic 中通総合病院眼科(秋田県) Nakadori General Hospital 新津あさくら眼科クリニック(岩手県) Niitsu Asakura Eye Clinic 馬場町眼科クリニック(青森県) Babacho Eye Clinic 大原総合病院眼科(福島県) Oohara General Hostital 黒滝眼科(青森県) Kurotaki Eye Clinic 仙台市立病院（宮城県）Sendai City Hospital

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 31 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	2010 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 02 Day
Date trial data considered complete	2019 Year 03 Month 02 Day
Date analysis concluded	2019 Year 03 Month 02 Day

Other
Other related information

Management information
Registered date	2010 Year 08 Month 24 Day
Last modified on	2019 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004928

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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