UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012582 |
|---|---|
| Receipt number | R000010443 |
| Scientific Title | Aiphagan addition to prostaglandin analogue(PG) and/or beta-blocker and/or carbonic anhydrase inhibitor in normal pressure glaucoma study |
| Date of disclosure of the study information | 2013/12/15 |
| Last modified on | 2013/12/15 17:18:31 |
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Basic information
Public title
Aiphagan addition to prostaglandin analogue(PG) and/or beta-blocker and/or carbonic anhydrase inhibitor in normal pressure glaucoma study
Acronym
AABC study
Scientific Title
Aiphagan addition to prostaglandin analogue(PG) and/or beta-blocker and/or carbonic anhydrase inhibitor in normal pressure glaucoma study
Scientific Title:Acronym
AABC study
Region
| Japan |
Condition
Condition
Normal tension glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the efficacy and safety of 0.1% brimonidine tartrate ophthalmic solution (0.1% brimonidine) preserved with sodium chlorite as add-on therapy in Japanese normal-tension glaucoma (NTG) patients who use prostaglandin analogues as first line therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
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
Added to 0.1% brimonidine tartrate 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients under treatment with prostagrandine and/or beta blockers who are judged to require the addition of Brimonidine with be not able to achieve target IOP as on their current IOP lowering monotherapy.
2.On treatment IOPs of bilateral eyes were between 13 and 16 mmHg in at least three consecutive measurements without changing the prescription for three months or more; patients with an IOP of 10 to 12 mmHg were eligible if the central corneal thickness (CCT) was 470 micro meter or less.
3.Visual aquity is equall or more 0.5
4. Correction is under -10 diopter.
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 betablockers.
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
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Yoshikawa |
Organization
Yoshikawa Eye Clinic
Division name
Ophthalmology Director
Zip code
Address
1-3-1 Nakamachi Machida-city Tokyo
TEL
042-739-0781
keiyomd@ark.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoaki Tsumura |
Organization
Fussa Hospital
Division name
Ophthalmology
Zip code
Address
1-6-1 Kamidaira Fussa-city Tokyo
TEL
042-551-1111
Homepage URL
tsumura@fussahsp.jp
Sponsor or person
Institute
AABC study group
Institute
Department
Personal name
Funding Source
Organization
None
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
公立福生病院（東京都）、吉川眼科クリニック（東京都）、中野総合病院（東京都）、上野眼科医院（東京都）、神楽坂みなみの眼科（東京都）、入間川病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | 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
| 2012 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 15 | Day |
Last modified on
| 2013 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010443
