UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032503 |
|---|---|
| Receipt number | R000037068 |
| Scientific Title | Evaluation of contact lens wettability while wearing soft contact lens |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2018/10/18 10:11:15 |
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Basic information
Public title
Evaluation of contact lens wettability while wearing soft contact lens
Acronym
Evaluation of contact lens wettability
Scientific Title
Evaluation of contact lens wettability while wearing soft contact lens
Scientific Title:Acronym
Evaluation of contact lens wettability
Region
| Japan |
Condition
Condition
Patients using soft contact lenses for more than five days a week
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to evaluate and compare contact lens wettability among three kinds of soft contact lens 8 hour after wearing soft contact lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation contact lens wettability 8 hour after wearing soft contact lens.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Silicone Hydrogel Contact Lens
Interventions/Control_2
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Patients using soft contact lenses for more than five days a week
2)Patients who BUT is 5 or more than 5 seconds and do not have dry eye
3)Patients who wear soft spherical contact lenses (not for perspective or astigmatism)
4)Spherical power is -5.75 D and less than -5.75D
5)Women aged 20 years and under 45 years of age at the time of consent acquisition
6)A patient who understands the contents of the consent document and is able to consent in the document of the person
7)Patient who can come to the observation day by the instruction of the researcher
Key exclusion criteria
1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye
2)Patients who have allergy and infectious ocular conditions.
3)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research
4)Patients judged by other research managers or researchers as inappropriate to implement this research safely
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Ishizuchi Eye Clinic
Division name
Director
Zip code
Address
1-8-30 Shonaicho Niihama-city Ehime
TEL
0897-33-3069
t-suzuki@ishizuchi-eye-clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Ishizuchi Eye Clinic
Division name
Director
Zip code
Address
1-8-30 Shonaicho Niihama-city Ehime
TEL
0897-33-3069
Homepage URL
t-suzuki@ishizuchi-eye-clinic.jp
Sponsor or person
Institute
Ishizuchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Bausch Lomb Japan
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
| 2018 | Year | 05 | Month | 08 | 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
| 2018 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 08 | 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
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2018 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037068
