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 |
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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
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
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
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
