UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017723
Receipt number R000020529
Scientific Title Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye
Date of disclosure of the study information 2015/07/01
Last modified on 2020/07/15 13:21:32

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye

Acronym

Safety and Efficacy of Excision of Horizontal Canaliculus

Scientific Title

Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye

Scientific Title:Acronym

Safety and Efficacy of Excision of Horizontal Canaliculus

Region

Japan


Condition

Condition

aqueous deficient type of dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy of horizontal canalicular excision for severe aqueous deficient type of dry eyes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intra- and post-operative complications of horizontal canalicular excision
occlusion rate of horizontal canalicular excision
change in tear meniscus height
improvement of ocular surface epithelial damage

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

once horizontal canalicular excision

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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

1. both of in- and out-patients
2. over 20 years old at the entry
3. dry eye patients diagnosed using the 2006-version criteria of dry eye
4. primary and secondary dry eyes
5. patients who had the history failed punctal occlusion using either punctal plug or surgical procedure

Key exclusion criteria

1. patients having active ocular disease other than dry eyes
2. patients having the problem of general condition
3. patients who are decided to inappropriate as subjects

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Seika
Middle name
Last name Den

Organization

Tokyo Dental College Ichikawa General Hospital

Division name

Department of Ophthalmology

Zip code

2728513

Address

5-11-13, Sugano, Ichikawa, Chiba, Japan

TEL

047-322-0151

Email

dens@tdc.ac.jp


Public contact

Name of contact person

1st name Seika
Middle name
Last name Den

Organization

Tokyo Dental College Ichikawa General Hospital

Division name

Department of Ophthalmology

Zip code

2728513

Address

5-11-13, Sugano, Ichikawa, Chiba, Japan

TEL

047-322-0151

Homepage URL


Email

dens@tdc.ac.jp


Sponsor or person

Institute

Tokyo Dental College Ichikawa General Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Tokyo Dental College

Address

5-11-13, Sugano, Ichikawa, Chiba, Japan

Tel

0473220151

Email

dens@tdc.ac.jp


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 07 Month 01 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

13

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

Main results already published

Date of protocol fixation

2015 Year 05 Month 07 Day

Date of IRB

2015 Year 05 Month 11 Day

Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2019 Year 04 Month 30 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 05 Month 28 Day

Last modified on

2020 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020529


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name