UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002017
Receipt number R000002460
Scientific Title Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma
Date of disclosure of the study information 2009/06/15
Last modified on 2012/06/02 15:50:13

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Basic information

Public title

Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma

Acronym

Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma

Scientific Title

Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma

Scientific Title:Acronym

Evaluation of the Intraocular pressure lowering effect of Tafluprost and Latanoprost on normal tension Glaucoma

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of Taflurost and Latanoprost on intraocular pressure and safety in normal-tension glaucoma in randomized, open-labeled, crossover, study

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy: Intraocular Pressure Lowering rate

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tafluprost monotherapy of 12weeks, Latanoprost monotherapy of 12weeks and if possible, continue monotherapy with either ophthalmic solution for 52weeks

Interventions/Control_2

Latanoprost monotherapy of 12weeks, Tafluprost monotherapy of 12weeks and if possible, continue monotherapy with either ophthalmic solution for 52weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Diagnosed with normal-tension glaucoma
2. Person whose agreement is shown by him/herself
3. Over 20 years old on the date of agreement.
4. Both male and female
5. Outpatient treatment
6. Having latanoprost monotherapy treatment more than 4 weeks and whose intraocular pressure is between 10 mmHg and 21 mmHg.
7. Over 0.1 of corrected visual acuity with an eye for evaluation.
8. If both eyes can be evaluated, an eye with higher intraocular pressure will be chosen for evaluation.

Key exclusion criteria

1. Severe visual field defect (Ex:HFA <-15dB)
2. Any corneal abnormality or other condition preventing reliable applanation tonometry.
3. Presence of any external ocular disease, inflammation or infection of the eye and/or eyelids.
4. History of refractive surgery.
5. Diagnosed with degenerative miopia
6. History of laser trabeculoplasty, filtering surgery, trabeculotomy, or cataract surgery within 6 months.
7. Presence of any hypersensitivity to test drugs.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Mori

Organization

Kyoto Prefectural University of Medicine

Division name

Department of ophthalmology

Zip code


Address

Hirokoji Kawaramachi Kamigyo-ku Kyoto 602-0841

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Mori, Morio Ueno, Yoko Ikeda

Organization

Kyoto Prefectural University of Medicine

Division name

Department of ophthalmology

Zip code


Address


TEL

075-251-5578

Homepage URL


Email



Sponsor or person

Institute

Department of ophthalmology, Kyoto Prefectural University of Medicine

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


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

2009 Year 06 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


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

2009 Year 05 Month 13 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 05 Month 29 Day

Last modified on

2012 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002460


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name