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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Glaucoma | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_7 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 120 |
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Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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