UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004093 |
|---|---|
| Receipt number | 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 17:28:49 |
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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
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
michinok@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Akita Univ. School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004928
