UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of curative effect of latanoprost and unoprostone in patients with nomal tension glaucoma (IOP<=15mmHg).
Title of the study (Brief title)	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	Kazuhisa Sugiyama
Organization	Kanazawa University
Division name	Department of Ophthalmology
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Email

Public contact
Name of contact person	Kazuhisa Sugiyama
Organization	Kanazawa University
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013205