UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039491
Receipt number R000045003
Scientific Title Evaluation of Diquafosol after femtosecond laser-assisted cataract surgery
Date of disclosure of the study information 2020/02/15
Last modified on 2021/03/16 14:08:34

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Basic information

Public title

Evaluation of Diquafosol after femtosecond laser-assisted cataract surgery

Acronym

Evaluation of Diquafosol

Scientific Title

Evaluation of Diquafosol after femtosecond laser-assisted cataract surgery

Scientific Title:Acronym

Evaluation of Diquafosol

Region

Japan


Condition

Condition

dry eye

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy of diquafosol after femtosecond laser-assisted cataract surgery for dry eye

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fidings of cornea, visual acuiaty

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

diquafosol treatment (6 times a day) or non treatment

Interventions/Control_2

diquafosol treatment for 30 days

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients after femtosecond-laser-assisted cataract surgery for both eyes

Key exclusion criteria

severe glaucoma, severe diabetic retinopathy,

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kenichiro
Middle name
Last name Yamazaki

Organization

Omiya Nanasato Eye Institute

Division name

Ophthalmology

Zip code

3370017

Address

678-1, Fittono, Minuma ward, Saitama City, Saitama pref.

TEL

81-48-686-7000

Email

karamawari@msn.com


Public contact

Name of contact person

1st name Kenichiro
Middle name
Last name Yamazaki

Organization

Omiya Nanasato Eye Institute

Division name

Ophthalmology

Zip code

3370017

Address

678-1, Fittono, Minuma ward, Saitama City, Saitama pref.

TEL

81-48-686-7000

Homepage URL


Email

karamawari@msn.com


Sponsor or person

Institute

Omiya Nanasato Eye Institute

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Omiya Nanasato Eye Institute

Address

678-1, Fittono, Minuma ward, Saitama City, Saitama pref.

Tel

81-48-686-7000

Email

karamawari@msn.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

2020 Year 02 Month 15 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

24

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

2020 Year 01 Month 15 Day

Date of IRB

2020 Year 02 Month 01 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 07 Month 01 Day

Date trial data considered complete

2020 Year 07 Month 01 Day

Date analysis concluded

2020 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2020 Year 02 Month 15 Day

Last modified on

2021 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name