UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054676 |
|---|---|
| Receipt number | R000062455 |
| Scientific Title | Effect of Eye Wash solution on Contact Lens Discomfort (CLD) |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/06/17 08:49:49 |
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Basic information
Public title
Effect of Eye Wash solution on Contact Lens Discomfort (CLD)
Acronym
Effect of Eye Wash solution on Contact Lens Discomfort
Scientific Title
Effect of Eye Wash solution on Contact Lens Discomfort (CLD)
Scientific Title:Acronym
Effect of Eye Wash solution on Contact Lens Discomfort
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of eye wash on contact lens discomfort (CLD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1: Evaluation of J-CLDEQ-8 scores
Key secondary outcomes
2: Evaluation of conjunctival vascular occupancy
3: Evaluation of noninvasive interferometry break up time
4: Evaluation of mucin content in tear fluid
5: Evaluation of tear fluid volume
6: Determination of the amount of total protein adhered to contact lenses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
Eyebon mild
Interventions/Control_2
Saline solution
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
1.Healthy subjects whose age of 20 years or more and 60 years or less
2.Subjects of soft contact lens user
3.Subjects who scored 11 or higher on the J-CLDEQ-8 questionnaire
4.Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1.Subjects diagnosed with ocular Xerophthalmia(dry eye syndrome)
2.Subjects who have experienced adverse reactions such as skin rash, redness, itching, redness of the skin, redness of the eyes, itching or swelling of the eyes due to the use of eye washes in the past
3.Subjects with severe eye pain
4.Subjects who used eye washes or eye drops outside the study during the study period
5.Subjects infected with HBV, HCV, HIV, etc
6.Subjects who the investigator considers ineligible for enrolment
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Ito |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
R&D Healthcare Division
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka567-0057, Japan
TEL
080-7552-1583
ke.ito@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Ito |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
R&D Healthcare Division
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka567-0057, Japan
TEL
080-7552-1583
Homepage URL
ke.ito@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1590
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 06 | Month | 19 | 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
23
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062455
