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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007522
Receipt No. R000008865
Scientific Title Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Date of disclosure of the study information 2012/04/01
Last modified on 2012/03/18

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Basic information
Public title Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Acronym Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Scientific Title Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Scientific Title:Acronym Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Region
Japan

Condition
Condition ocular inflammation after cataract surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare bromfenac sodium alone to combination use of a steroidal ophtalmic solution in priventing ocular inflammation after cataract surgery in diabetic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Clinical test items such as best corrected visual acuity, slit lamp microscopy, amount of anterior chamber flare and cells mesured laser flare cell photometry, corneal thickness and retinal thickness were recorded each visit, preoperatively, 2day, 1week, 2weeks, 4weeks, 8weeks after cataract surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bromfenac sodium was administrated to eye after cataract surgery two times per day for 1day to 8weeks.
Interventions/Control_2 Steroidal ophthalmic solution was administrated to eye after cataract surgery four times per day for 1day to 2weeks and bromfenac sodium was administrated two times per day for 1day to 8weeks.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Diabetic patients(HbA1c over 6.0%) with cataract(Emery-Little classification grade4 or lower).
Key exclusion criteria Eyes allergic to bromfenac or steroid, eyes previously and post operatively underwent intraocular surgery of any type, history of uveitis, patients with severe cardiac incompetence or cereberovascular disorder and patient undergo hemo dialysis.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Miyata
Organization Miyata eye hospital
Division name department of ophthalmology
Zip code
Address 6-3 Kurahara-machi Miyakonojyo-shi, Miyazaki
TEL 0986-22-1441
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Terada
Organization Miyata eye hospital
Division name department of ophthalmology
Zip code
Address
TEL
Homepage URL
Email terada@miyata-med.ne.jp

Sponsor
Institute Miyata eye hospital
Institute
Department

Funding Source
Organization Miyata eye hospital
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
2012 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
2011 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2011 Year 11 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
2012 Year 03 Month 18 Day
Last modified on
2012 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008865

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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