UMIN-CTR Clinical Trial

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
Last 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
Email	tmatsu@u-fukui.ac.jp

Public contact
1st 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
Email	tmatsu@u-fukui.ac.jp

Sponsor
Institute	Department of Ophthalmology, Faculty of Medical Science, University of Fukui
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020790