UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Autologous serum eye drops with added hyaluronic acid: a noncontrastive analysis of the effect on keratconjunctival disorder
Title of the study (Brief title)	A noncontrastive analysis of autologous serum eye drops with added hyaluronic acid
Region	Japan

Condition
Condition	keratoconjunctival dysfunction,severe dry eye,late-onset bleb leak after trabeculectomy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of autologous serum eye drops with added hyaluronic acid
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	evaluation of keratconjunctival disorder with slit lamp, visual acuity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	autologous serum eye drops added hyaluronic acid(autologous serum50%,hyaleinmini0.3,33%,cravit16.7%)
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	paient with severe keratoconjunctival dysfunction
Key exclusion criteria	patient who has allergy to hyaleinmini0.3 and cravit
Target sample size	100

Research contact person
Name of lead principal investigator	Tetsuju Sekiryu
Organization	Department of Ophthalmology, Fukushima Medical University School of Medicine
Division name	professor
Address	1Hikariga-oka, Fukushima City, 960-1295 JAPAN
TEL	024-547-1111(2393)
Email	sekiryu@fmu.ac.jp

Public contact
Name of contact person	Hideto Sagara
Organization	Marui Eye Clinic
Division name	Director
Address	1-83-3, Honjinmae Haramachi-ku, Minamisoma City, Fukushima Prefecture 975-0062, Japan
TEL	0244-25-7488
Homepage URL
Email	hide1234@ruby.ocn.ne.jp

Sponsor
Institute	Marui Eye Clinic, Department of Ophthalmology Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization	Marui Eye Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2009 Year 11 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 05 Day
Anticipated trial start date	2008 Year 03 Month 01 Day
Last follow-up date	2018 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2009 Year 11 Month 02 Day
Last modified on	2018 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003021