UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017934 |
|---|---|
| Receipt number | R000020790 |
| Scientific Title | Proof of concept trial of bromfenac ophthalmic solution for inhibitory effect against inflammatory cytokines. |
| Date of disclosure of the study information | 2015/08/24 |
| Last modified on | 2019/03/27 12:28:15 |
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Basic information
Public title
Proof of concept trial of bromfenac ophthalmic solution for inhibitory effect against inflammatory cytokines.
Acronym
Proof of concept trial of bromfenac ophthalmic solution for inhibitory effect against inflammatory cytokines.
Scientific Title
Proof of concept trial of bromfenac ophthalmic solution for inhibitory effect against inflammatory cytokines.
Scientific Title:Acronym
Proof of concept trial of bromfenac ophthalmic solution for inhibitory effect against inflammatory cytokines.
Region
| Japan |
Condition
Condition
Patients with pseudophakic eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of
0.1% bromfenac sodium ophthalmic solution in the prevention of bleb scarring after trabeculotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the cytokine concentration difference (before and 8 days after drug administration) between test drug groups
Key secondary outcomes
Comparison of the cytokine concentration between before and 8 days after drug administration in the same group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.1% bromfenac sodium ophthalmic solution;
One drop once, twice a day, instilled for 8 days
Interventions/Control_2
0.02% fluorometholone ophthalmic suspension;
One drop once, twice a day, instilled for 8 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with the document agreement
2)Pseudophakic eye
3)Patients with the periods of three months or more after the end of the instillation of steroid and NSAIDs ophthalmic solution for post cataract operation
Key exclusion criteria
1)Patients with a history of hypersensitivity against bromfenac and fluorometholone
2)Patients with ocular infections and inflammation (including allergic conjunctivitis and vernal keratoconjunctivitis)
3)Patients who received the ophthalmic surgery (including laser) within three months.
4)Patients with systemic diseases that may affect the efficacy or safety of the test drugs
5)Patients who was judged to be inappropriate as a subject by doctor in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Matsumura |
Organization
University of Fukui, Faculty of medicine
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-3111
tmatsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Matsumura |
Organization
University of Fukui, Faculty of medicine
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8403
Homepage URL
tmatsu@u-fukui.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Science, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Support Center, Faculty of Medical Science, University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776-61-8529
chiken@ml.u-fukui.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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 24 | 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
27
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
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020790
