UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019050
Receipt number R000020166
Scientific Title Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops
Date of disclosure of the study information 2015/09/17
Last modified on 2017/08/01 11:23:10

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Basic information

Public title

Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops

Acronym

The adjustment force recovery of presbyopia
by pirenoxine eye drops

Scientific Title

Study of the lens adjustment force recovery of early presbyopic eyes by pirenoxine eye drops

Scientific Title:Acronym

The adjustment force recovery of presbyopia
by pirenoxine eye drops

Region

Japan


Condition

Condition

presbyopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the possibility that pirenoxine eye drops can recover the lens adjustment force.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of accommodation amplitude (subjective&objective) after 6 month administration of eye drops.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is 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

Use Kary Uni eyedrops four times a day for 6 months

Interventions/Control_2

Use Soft Santear eyedrops four times a day for 6 months

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

40 years-old <=

Age-upper limit

55 years-old >

Gender

Male

Key inclusion criteria

The inclusion criteria are male, patient age of 20 years and older, and no ophthalmic or systematic diseases other than refractive errors.

Key exclusion criteria

Ophthalmic or systematic diseases other than refractive errors, past ophthalmic operations, myopia of -6D or more, hyperopia.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University school of medicine

Division name

Ophthalmology

Zip code


Address

35, Shinanomachi, Shinjuku-ku Tokyo

TEL

+81-3-3353-1211

Email

fwic7788@mb.infoweb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University school of medicine

Division name

Ophthalmology

Zip code


Address

35, Shinanomachi, Shinjuku-ku Tokyo

TEL

+81-3-3353-1211

Homepage URL


Email

fwic7788@mb.infoweb.ne.jp


Sponsor or person

Institute

Keio University School of medicine

Institute

Department

Personal name



Funding Source

Organization

Kazuno Negishi

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


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

2015 Year 09 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.nature.com/articles/%20s41598-017-07208-6

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

2015 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2016 Year 08 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 09 Month 17 Day

Last modified on

2017 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/08/01 データまとめシート.xlsx