UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007820 |
|---|---|
| Receipt number | R000001265 |
| Scientific Title | A Randamized, Prospective and Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma |
| Date of disclosure of the study information | 2012/04/23 |
| Last modified on | 2018/04/28 16:19:26 |
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Basic information
Public title
A Randamized, Prospective and Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Acronym
A Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Scientific Title
A Randamized, Prospective and Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Scientific Title:Acronym
A Comparative Study of Topical Timolol and Latanoprost in Uveitic Glaucoma
Region
| Japan |
Condition
Condition
Uveitic Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated effects on the intraocular pressure (IOP) lowering and safety of topical timolol and latanoprost in UG prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure-lowering ratio
Key secondary outcomes
1)flare value in the anterior chamber
2)side effects(conjunctival injection, corneal erosion)
3)macular thickness measured by OCT
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
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Latanoprost eye drop
Interventions/Control_2
Timolol-XE eye drop
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)The patients received topical corticosteroid for uveitis.
2) There was no strong inflammation in the anterior chamber within these 3 months.
3) The objective eyes didn't received anti-glaucoma eye drops.
4) 30mmHg> Baseline IOP (before starting treatment) >=21mmHg
Key exclusion criteria
1) herpetic iritis
2) PAS index>25% (secondary angle closure glaucoma)
3) The patients who received Argon Laser Trabeculoplasty within 3 months.
4) The patients who received intraocular surgeries within 6 months.
5)The patients who had asthma or arrythmia, and couldn't receive timolol.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshikatsu Kaburaki |
Organization
University of Tokyo Hospital
Division name
Ophthalmology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-3815-5411
kabutosi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshikatsu Kaburaki |
Organization
University of Tokyo Hospital
Division name
Ophthalmology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-3815-5411
Homepage URL
kabutosi-tky@umin.ac.jp
Sponsor or person
Institute
Deportment of Ophthalmology, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Deportment of Ophthalmology, University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Ophthalmology, Teikyo University Hospital
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
東京大学附属病院眼科(東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 23 | 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
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001265
