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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004093
Receipt No. R000004928
Scientific Title Comparison of tafluprost and latanoprost on progression of visual field loss in primary open angle glaucoma: prospective, randomized, open, multi-center study.
Date of disclosure of the study information 2010/10/31
Last modified on 2019/03/02

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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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