UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004760 |
|---|---|
| Receipt number | R000005667 |
| Scientific Title | The long term effect of NSAIDs on travoprost induced conjunctival hyperemia and IOP reduction in normal eyes |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2010/12/20 21:56:01 |
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Basic information
Public title
The long term effect of NSAIDs on travoprost induced conjunctival hyperemia and IOP reduction in normal eyes
Acronym
Interaction between travoprost and NSAIDs
Scientific Title
The long term effect of NSAIDs on travoprost induced conjunctival hyperemia and IOP reduction in normal eyes
Scientific Title:Acronym
Interaction between travoprost and NSAIDs
Region
| Japan |
Condition
Condition
normal eyes
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship of prostaglandin-related ocular hypotensive drugs and endogenous produced prostaglandins associated with intraocular pressure (IOP) and ocular side effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IOP reduction, hyperemia, superficial punctate keratopathy (SPK)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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. Flavin adenine dinucleotide (FAD) solution was dropped two times a day during 28 days. In the second day, at 9AM, travoprost was dropped once a day during 27 days.
Interventions/Control_2
Treated group; Contralateral 30 eyes. Bromfenac Na solution was dropped two times a day during 28 days. In the second day, at 9AM, travoprost was dropped once a day during 27 days.
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 diseases
2.Past history of ocular surgery
3.Allergy for NSAIDs or PG-related drugs
4.Wearing contact lenses during the study
5.Participation in other clinical researches within 6 months
6.Using glaucoma drugs
7.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 Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo, Japan
TEL
03-5800-8660
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rei Sakata |
Organization
University of Tokyo, Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo, Japan
TEL
03-5800-8660
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, University of Tokyo, Faculty of Medicine
Institute
Department
Personal name
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
まつお眼科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 21 | 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
| 2010 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 20 | Day |
Last modified on
| 2010 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005667
