UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021319
Receipt number R000024591
Scientific Title Effect of Eyewash Solution (Commercial washing solution) on the Corneal Epithelium: Adverse Effects of Benzalkonium Chloride on the Eye Surface
Date of disclosure of the study information 2016/03/03
Last modified on 2016/03/11 20:02:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of Eyewash Solution (Commercial washing solution) on the Corneal Epithelium: Adverse Effects of Benzalkonium Chloride on the Eye Surface

Acronym

Effect of Eyewash Solution (Commercial washing solution) on the Corneal Epithelium

Scientific Title

Effect of Eyewash Solution (Commercial washing solution) on the Corneal Epithelium: Adverse Effects of Benzalkonium Chloride on the Eye Surface

Scientific Title:Acronym

Effect of Eyewash Solution (Commercial washing solution) on the Corneal Epithelium

Region

Japan


Condition

Condition

allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In recent years, there has been an increasing interest in eye washing in healthy individuals due to pollinosis and an increase in the number of people wearing contact lenses. Previously, commercial eyewash solutions contained a preservative (benzalkonium chloride [BAK]) that was shown to be associated with epithelium disorders. However, currently, a reduction in corneal epithelium disorders is assumed to be due to the popularization of eyewash solutions lacking BAK (over-the counter drugs).
Therefore, in this study, we observed the effects of eyewash solutions on the corneal epithelium experimentally using rabbits, to examine the presence or absence of BAK in the eyewash solutions currently on the market, and their effects on the corneal epithelium. We also conducted a clinical study on healthy individuals and comparatively examined objective findings in different eye wash solution groups.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Observation of corneal epithelium disorders
(1) Fluorescein vital staining
(2) Fluorophotometry
2. Evaluation of corneal epithelial mucin layer
(1) Lissamine green vital staining

Key secondary outcomes

Fluorescein staining (2microL) was performed and evaluated initially, by an ophthalmologist before eye washing. Eyes were washed with 20 mL of BSS-plus after 10 minutes to wash away the fluorescein stain solution and, 20 minutes later (30 minutes after fluorescein staining), fluorescein remaining on the cornea was measured using the fluorophotometry. Following this, evaluation by lissamine green staining (2microL) was performed. After eye washing, fluorescein staining evaluation, fluorophotometry measurements, and lissamine green staining evaluation were performed in the same manner as before eye washing, and the results were compared before and after eye washing.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eyebon W Vitamin
[Methods]
The subjects washed the right eye with the physiological saline solution as the control and the left eye with the respective test solutions without anesthesia. The eyes were washed for 30 seconds with 5 mL of the eyewash solution at a time using the eye cup for commercial eyewash solutions (eye cup attached to Eyebon W Vitamin). Eye washing was performed six times in total in 1-hour intervals, based on the upper limit specified in the dosage and administration.

Interventions/Control_2

Eyebon W Vitamin containing BAK
[Methods]
Same as above.

Interventions/Control_3

Physiological saline solution containing BAK
[Methods]
Same as above.

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

*Healthy individuals who had not used contact lenses for at least 1 day before the study.
*Healthy individuals aged 20 years and older at the time of informed consent.
*Healthy individuals that received a full explanation on the objectives and methods of the study, expected effects and adverse drug reactions, respect for the privacy, recompense and compensation, and who themselves or their legal representatives voluntarily provided consent for study participation.

Key exclusion criteria

Subject who the investigator considers ineligible for enrolment.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Fujishima

Organization

Tsurumi University

Division name

Faculty of Dentistry

Zip code


Address

2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.

TEL

045-580-8599

Email

fujishima117@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Fujishima

Organization

Tsurumi University

Division name

Faculty of Dentistry

Zip code


Address

2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.

TEL

045-580-8599

Homepage URL


Email

fujishima117@gmail.com


Sponsor or person

Institute

Tsurumi University

Institute

Department

Personal name



Funding Source

Organization

KOBAYASHI Pharmaceutical Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

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

2016 Year 03 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Japan Cornea Conference 2014 and 2015
ARVO 2015 Annual Meeting

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

2013 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2016 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name