臨床研究等提出・公開システム

Date of registration	April. 20, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220721

Scientific Title	Phase II Study of 0.15% UF-021 in patients with retinitis pigmentosa
Public Title	Phase II Study of 0.15% UF-021 in patients with retinitis pigmentosa

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	R-tech Ueno, Ltd
	Address	http://www.rtechueno.com/contact_jp.php
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		105
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, parallel-three groups study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Decimal visual acuity: 0.5 or better With abnormal visual field measured by the Goldmann perimetry
	Exclusion Criteria	The subject has taken steroids and/or vasodilators within 1 month prior to informed consent.
	Minimum Age	20age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		retinitis pigmentosa
Intervention(s)		investigational material(s) Generic name etc : UF-021 (isopropyl unoprostone) INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : Eye drop
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety
Secondary Outcome

Primary Sponsor	R-Tech Ueno, Ltd
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090748
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Feb. 27, 2013	Detail	Changes
6	Feb. 27, 2013	Detail	Changes
5	Aug. 10, 2010	Detail	Changes
4	Aug. 10, 2010	Detail	Changes
3	Aug. 27, 2009	Detail	Changes
2	April. 20, 2009	Detail	Changes
1	April. 20, 2009	Detail

List of change history