UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011320 |
|---|---|
| Receipt number | R000013205 |
| Scientific Title | Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg). |
| Date of disclosure of the study information | 2013/07/30 |
| Last modified on | 2018/08/17 15:05:51 |
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Basic information
Public title
Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg).
Acronym
Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg).
Scientific Title
Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg).
Scientific Title:Acronym
Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg).
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To study MD of baseline and 3 years later using latanoprost and unoprostone.
Key secondary outcomes
1) To study CPSD or TD of baseline and 3 years later using latanoprost and unoprostone.
2) To study transition MD, CPSD or TD of baseline to 3 years later using latanoprost and unoprostone.
3) To comparare MD, CPSD or TD between groups of using latanoprost and unoprostone for 3 years.
4) To study transition IOP of baseline to 3 years later using latanoprost and unoprostone.
5) To comparare IOP between groups of using latanoprost and unoprostone.
6) Adverse events in each groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using latanoprost for 3 years.
Interventions/Control_2
Using unoprostone for 3 years.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with normal tension glaucoma setting following conditions.
1)IOP <= 15 mmHg in no medication.
2)MD >= -12 dB and difference of right and left MD <= 6 dB.
3)Not applicable to contraindication or careful administration of these drugs.
4)Corrected visual acuity >= 0.8
5)Spherical refraction is within –9D to +9D.
6)Difference of right and left Spherical refraction <=3D
7)No any intraocular eye disease
8)No history of intraocular surgery or laser treatment.
9)Subjects who agree to the participation in this study.
Key exclusion criteria
Patients not satisfying the above conditions
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukui Saiseikai Hospital / Ophthalmology
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013205
