UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007028 |
|---|---|
| Receipt number | R000008293 |
| Scientific Title | Assessing the efficacy of changing to Travoprost/Timolol fixed combination, as replacement therapy in patients on prostaglandin monotherapy |
| Date of disclosure of the study information | 2012/01/06 |
| Last modified on | 2012/01/06 18:03:36 |
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Basic information
Public title
Assessing the efficacy of changing to Travoprost/Timolol fixed combination, as replacement therapy in patients on prostaglandin monotherapy
Acronym
Assessing the efficacy of changing to Travoprost/Timolol fixed combination, as replacement therapy in patients on prostaglandin monotherapy
Scientific Title
Assessing the efficacy of changing to Travoprost/Timolol fixed combination, as replacement therapy in patients on prostaglandin monotherapy
Scientific Title:Acronym
Assessing the efficacy of changing to Travoprost/Timolol fixed combination, as replacement therapy in patients on prostaglandin monotherapy
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess
the efficacy of changing to Travoprost/Timolol fixed combination in patients with glaucoma or ocular hypertension,who can not achieve target IOP while on their current IOP-lowering
monotherapy(travoprost, tafluprost,
latanoprost, bimatoprost).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy
IOP value;IOP-lowering effect from baseline(reduced value;reduction rate%)
Key secondary outcomes
Safety
1.Ocular safety assessment:
Conjunctival hyperemia,adverse events
2.Systemic safety assessment:
Blood pressure,the pulse,adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Travoprost/Timolol fixed combination ophthalmic solution for 3 months
Interventions/Control_2
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.Age at the time of the agreement 20 years old or older.
2.Gender and outpatient or the hospitalization are no object.
3.Must have been treated monotherapy with PGAs for 3 months or longer for the study eye, by the time of baseline examinations.
4.Patients who are judged to require the switch of Duotrav with be not able to achieve target IOP as on their current IOP-lowering monotherapy
Key exclusion criteria
1.Complications with chronic or recurrent uveitis,scleritis,or corneal herpes.
2.History of ocular trauma or intraocular conventional surgery or laser ocular surgery in the study eye within 3 months before baseline examinations.
3.Any abnormality preventing reliable applanation tonometer in the study eye.
4.Known medical history of allergic to PGAs or beta-blockers. 5.Contraindication of beta-blockers
6.Patients using an IOP-lowering drug other than those to be used in the study.
7.Patients using systemic administration of an oral CAI (Diamox,etc.)
8.Patient having serious eyes complications
9.Women who are pregnant or lactating
10.Severe dementia
11.Patients who are judged to be inappropriate for participation in the study for other reason by the doctor in charge.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Yoshikawa |
Organization
Yoshikawa Eye Clini
Division name
Ophthalmology Director
Zip code
Address
1-3-1 Nakamachi Machida-city Tokyo
TEL
042-739-0781
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Nakano |
Organization
The Jikei University
Division name
Ophthalmology
Zip code
Address
3-19-18Nishishinbashi minato-ku
TEL
03-3433-1111
Homepage URL
tnakano@jikei.ac.jp
Sponsor or person
Institute
I.CHANGE study group
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Health Service Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
吉川眼科クリニック（東京都）、東北大学(宮城県)、南松山病院（愛媛県）、東京慈恵会医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
