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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001172
Receipt No. R000001423
Scientific Title Anti-inflamation effect of Bromfenac ophthalmic solution after selective laser trabeculoplasty.
Date of disclosure of the study information 2008/06/15
Last modified on 2009/12/07

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Basic information
Public title Anti-inflamation effect of Bromfenac ophthalmic solution after selective laser trabeculoplasty.
Acronym Anti-inflamation effect of Bromfenac ophthalmic solution after selective laser trabeculoplasty.
Scientific Title Anti-inflamation effect of Bromfenac ophthalmic solution after selective laser trabeculoplasty.
Scientific Title:Acronym Anti-inflamation effect of Bromfenac ophthalmic solution after selective laser trabeculoplasty.
Region
Japan

Condition
Condition Primary Open Angle Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare anti-inflamation effect of a bromfenac sodium to a steroid ophthalmic solution after selective laser trabeculoplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Best corrected visual acuity, intraocular pressure, amount of anterior chamber cells and flare measured by laser cell flare photometry, number of corneal endthelial cells.

recorded each visit, preoperatively, 1day, 1 week, 1month, 3month, 6month after selective laser trabeculoplasty.
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 NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bromfenac ophthlamic solution was administrated to eye after selective laser trabeculoplasty two times per day for 1 week.
Interventions/Control_2 Steroid ophthlalmic solution was administrated to eye after selective laser trabeculoplasty four times per day for 1 week.
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
35 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients after laser trabeculoplasty for primary open angle glaucoma.
Key exclusion criteria Eyes allergic to bromfenac or steriod ophthalmic solution.
Eyes previously underwent intraocular surgery or laser surgery of any type within 3 months.
Eyes with history of PE glaucoma, uveitis.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaya Miyawaki
Organization Kozawa Eye Hospital and Diabetes Center
Division name ophthalmology
Zip code
Address 246-6, Yoshizawa-cho, Mito City, Ibaraki Pref.
TEL 029-246-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kozawa Eye Hospital and Diabetes Center
Division name ophthalmology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kozawa Eye Hospital and Diabetes Center
Institute
Department

Funding Source
Organization Kozawa Eye Hospital and Diabetes Center
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
2008 Year 06 Month 15 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 06 Month 02 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2009 Year 12 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
2008 Year 06 Month 03 Day
Last modified on
2009 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001423

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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