UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002194
Receipt number R000002680
Scientific Title Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time
Date of disclosure of the study information 2009/07/21
Last modified on 2014/01/23 23:41:47

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Basic information

Public title

Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time

Acronym

A study of autologous serum eye drops with added hyaluronic acid

Scientific Title

Autologous serum eye drops with added hyaluronic acid in the conjunctival sac: a study of the residual time

Scientific Title:Acronym

A study 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 hyaluronic acid to prolong the residual time of autologous serum eye drops in the conjunctival sac.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Albumin concentration in the conjunctival sac 10 min.,30min.,1hr and 3hrs.after administration of autologous serum eye drops added hyaluronic acid

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

apply 10 microliter autologous serum eye drops added hyaluronic acid(autologous serum50%,hyaleinmini0.3%,33%, cravit16.7%),48hrs,apply 10 microliter autologous serum eye drops added saline(autologous serum50%,saline33%,cravit16.7%)

Interventions/Control_2

apply 10 microliter autologous serum eye drops added saline(autologous serum50%,saline33%,cravit16.7%),48hrs,apply 10 microliter autologous serum eye drops added hyaluronic acid(autologous serum50%,hyaleinmini0.3,33%,cravit16.7%)

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

persons without severe keratoconjunctival dysfunction

Key exclusion criteria

paient with severe keratoconjunctival dysfunction

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideto Sagara

Organization

Marui Eye Clinic

Division name

Director

Zip code


Address

1-83-2, Honjinmae Haramachi-ku, Minamisouma, Fukushima 975-0062, Japan.

TEL

0244-25-7488

Email

hide1234@ruby.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideto sagara

Organization

Marui Eye Clinic

Division name

Director

Zip code


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 or person

Institute

Marui Eye Clinic

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2009 Year 07 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2009 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2012 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 07 Month 14 Day

Last modified on

2014 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002680


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name