UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010241
Receipt number R000011988
Scientific Title Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey
Date of disclosure of the study information 2013/03/14
Last modified on 2013/03/14 08:06:50

* 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

Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey

Acronym

Intraocular scattering after diquafosol eyedrops in dry eye

Scientific Title

Changes in Intraocular Scattering after Instillation of Diquafosol Ophthalmic Solution in Patients with Short Tear Breakup Time Type of Dry Ey

Scientific Title:Acronym

Intraocular scattering after diquafosol eyedrops in dry eye

Region

Japan


Condition

Condition

patients with short tear breakup time (TBUT) dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the changes in intraocular scattering before and after instillation of diquafosol ophthalmic solution in patients with short tear breakup time (TBUT) dry eye.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

objective scattering index (OSI)

Key secondary outcomes

tear breakup time (TBUT)


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and 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

3% diquafosol ophthalmic solution

Interventions/Control_2

Without 3% diquafosol ophthalmic solution

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

Short TBUT dry eye was diagnosed in patients when the TBUT values were equal to or shorter than 5 seconds, and the subjects had dry eye-related symptoms with no positive fluorescein staining or scores less than 3 points. All subjects were emmetropic or low-myopic with a visual acuity of 20/20 or better.

Key exclusion criteria

Any history of treatment for dry eye, previous ocular surgery, ocular trauma, contact lens use, punctual occlusion or diathermy, or eye disease including active inflammation of the eye, was excluded from the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenaga Kobashi

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 228-8555, Japan.

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address


TEL


Homepage URL


Email

himon@hotmail.co.jp


Sponsor or person

Institute

University of Kitasato School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The authors have no commercial or propriety interest in the product or company described in the current study.

Organization

Division

Category of Funding Organization

Other

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

2013 Year 03 Month 14 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

2011 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 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

2013 Year 03 Month 14 Day

Last modified on

2013 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011988


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name