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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021319
Receipt No. 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

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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
Institute Tsurumi University
Institute
Department

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
URL(English) https://upload.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


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