UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randamized, Prospective and Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Title of the study (Brief title)	A Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Region	Japan

Condition
Condition	Uveitic Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluated effects on the intraocular pressure (IOP) lowering and safety of topical timolol and latanoprost in UG prospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraocular pressure-lowering ratio
Key secondary outcomes	1)flare value in the anterior chamber 2)side effects(conjunctival injection, corneal erosion) 3)macular thickness measured by OCT

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	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Latanoprost eye drop
Interventions/Control_2	Timolol-XE eye drop
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patients received topical corticosteroid for uveitis. 2) There was no strong inflammation in the anterior chamber within these 3 months. 3) The objective eyes didn't received anti-glaucoma eye drops. 4) 30mmHg> Baseline IOP (before starting treatment) >=21mmHg
Key exclusion criteria	1) herpetic iritis 2) PAS index>25% (secondary angle closure glaucoma) 3) The patients who received Argon Laser Trabeculoplasty within 3 months. 4) The patients who received intraocular surgeries within 6 months. 5)The patients who had asthma or arrythmia, and couldn't receive timolol.
Target sample size	120

Research contact person
Name of lead principal investigator	Toshikatsu Kaburaki
Organization	University of Tokyo Hospital
Division name	Ophthalmology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL	03-3815-5411
Email	kabutosi-tky@umin.ac.jp

Public contact
Name of contact person	Toshikatsu Kaburaki
Organization	University of Tokyo Hospital
Division name	Ophthalmology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL	03-3815-5411
Homepage URL
Email	kabutosi-tky@umin.ac.jp

Sponsor
Institute	Deportment of Ophthalmology, University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Deportment of Ophthalmology, University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Ophthalmology, Teikyo University Hospital
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	東京大学附属病院眼科(東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 02 Month 01 Day
Anticipated trial start date	2008 Year 02 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2016 Year 03 Month 01 Day
Date trial data considered complete	2016 Year 06 Month 01 Day
Date analysis concluded	2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 23 Day
Last modified on	2018 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001265