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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034886 |
Receipt No. | R000039699 |
Official scientific title of the study | Effect of contact lens care on contact lens wettability while wearing soft contact lens |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2018/11/14 |
Basic information | ||
Official scientific title of the study | Effect of contact lens care on contact lens wettability while wearing soft contact lens | |
Title of the study (Brief title) | Effect of contact lens care on contact lens wettability | |
Region |
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Condition | ||
Condition | Patients using soft contact lenses for more than five days a week | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose is to compare water wettability on the soft contact lens using two kinds of soft contact lens care products. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Comparative evaluation of ophthalmic examinations after using two types of soft contact lens care products |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1)Patients using soft contact lenses for more than five days a week
2)Patients dryness score of CLDEQ-8 is greater than or equal to 4 points 3)Patients who BUT is 5 or more than 5 seconds and do not have dry eye 4)Patients who wear soft spherical contact lenses (not for perspective or astigmatism) 5)Spherical power is -5.75 D and less than -5.75D 6)Women aged 20 years and under 45 years of age at the time of consent acquisition 7)A patient who understands the contents of the consent document and is able to consent in the document of the person 8)Patient who can come to the observation day by the instruction of the researcher |
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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 |
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Target sample size | 10 |
Research contact person | |
Name of lead principal investigator | Takashi Suzuki |
Organization | Ishizuchi Eye Clinic |
Division name | Director |
Address | 1-8-30 Shonaicho Niihama-city Ehime |
TEL | 0897-33-3069 |
t-suzuki@ishizuchi-eye-clinic.jp |
Public contact | |
Name of contact person | Takashi Suzuki |
Organization | Ishizuchi Eye Clinic |
Division name | Director |
Address | 1-8-30 Shonaicho Niihama-city Ehime |
TEL | 0897-33-3069 |
Homepage URL | |
t-suzuki@ishizuchi-eye-clinic.jp |
Sponsor | |
Institute | Ishizuchi Eye Clinic |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039699 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |