UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001172 |
|---|---|
| Receipt number | 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 18:30:55 |
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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
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
Sponsor or person
Institute
Kozawa Eye Hospital and Diabetes Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001423
