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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011320
Receipt No. 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

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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 &#8211;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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, Kanazawa University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013205

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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