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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name