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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001475
Receipt No. R000001641
Scientific Title the effect of NSAIDs on travoprost-induced conjunctival hyperemia and IOP reduction in normal eyes
Date of disclosure of the study information 2009/04/01
Last modified on 2008/09/01

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Basic information
Public title the effect of NSAIDs on travoprost-induced conjunctival hyperemia and IOP reduction in normal eyes
Acronym interaction of travoprost and NSAIDs
Scientific Title the effect of NSAIDs on travoprost-induced conjunctival hyperemia and IOP reduction in normal eyes
Scientific Title:Acronym interaction of travoprost and NSAIDs
Region
Japan

Condition
Condition normal eyes
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship of prostaglandin-related ocular hypotensive drugs and endogenously produced prostaglandins in intraocular pressure reduction and ocular side effect
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes intraocular pressure reduction
hyperemia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 control group:30 eyes of randomly selected one of two eyes
Vehicle solution was dropped 3 times a day during 2 day.
In the second day, at 9, travoprost was dropped once.
Interventions/Control_2 treated group: contralateral 30 eyes
Dicrofenac Na was dropped 3 times a day during 2 day.
In the second day, at 9, travoprost was dropped once.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria ophthalmologically normal eyes
no systemic diseases
Key exclusion criteria 1.treated or treating ocular or systemic disease
2.past history of ocular surgery
3.allergy for NSAIDs or PG-related drugs
4.wearing contact lenses during the study
5.using glaucoma drugs
6.using steroid drugs topically or systemically
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Aihara
Organization University of Tokyo Faculty of Medicine
Division name Department of Ophthalology
Zip code
Address 7-3-1 Hongo Bunkyo Tokyo, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Aihara
Organization University of Tokyo Faculty of Medicine
Division name Department of Ophthalology
Zip code
Address 7-3-1 Hongo Bunkyo Tokyo, JAPAN
TEL 03-5800-8906
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, University of Tokyo Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, University of Tokyo Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyata Eye Hospital
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 04 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
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
2008 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2008 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 03 Day
Last modified on
2008 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001641

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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