UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017569 |
|---|---|
| Receipt number | R000020340 |
| Scientific Title | The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5 |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2017/11/14 11:57:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5
Acronym
Alcon Japan AZORGA Phase IV study
Scientific Title
The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5
Scientific Title:Acronym
Alcon Japan AZORGA Phase IV study
Region
| Japan |
Condition
Condition
Subjects with open angle glaucoma or ocular hypertension currently on PGA monotherapy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate non-inferiority of AZORGA Ophthalmic Suspension to COSOPT Ophthalmic Solution for IOL-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP change from baseline at 11 AM pooled over weeks (Week 4, Week 8)
Key secondary outcomes
IOP change from baseline at 9 AM pooled over weeks (Week 4, Week 8)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AZORGA group
AZORGA is assigned, and 1 drop is applied in both eyes twice daily, at 9 AM and 9 PM, for 8 weeks.
Interventions/Control_2
COSOPT group
COSOPT is assigned, and 1 drop is applied in both eyes twice daily, at 9 AM and 9 PM, for 8 weeks.
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)Patients who understand the nature of the study and voluntarily give written informed consent to participate in the study.
(2)Patients, 20 years of age or older.
(3)Patients diagnosed with open angle glaucoma or ocular hypertension.
(4)Patients who are on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and who will be allowed to instill only PGA for 4 weeks until the baseline visit.
(5)Patients whose IOP 15 mmHg (at least one same eye) both at 9 and 11 AM at the baseline visit.
Key exclusion criteria
excerpt:
(8) Patients with corneal disorder (reduced corneal endothelium cells, etc.). (9) Patients with a history of chronic, recurrent or current severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye.(10) Patients with a history of ocular trauma in either eye within six (6) months prior to the screening examination.(11) Patients with ocular infection or ocular inflammation in either eye.(12) Patients with a history of or current clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. (13) Patients with a history of intraocular surgery in either eye within six (6) months prior to the screening examination.(14) Patients with a history of ocular laser surgery in either eye within three (3) months prior to the screening examination. (15) Patients with any abnormality preventing reliable applanation tonometry of either eye. (16) Patients with a best-corrected visual acuity worse than 0.2 score (decimal visual acuity) in either eye(17) Patients with an angle Grade 2 or less in either eye by Shaffer classification. (18) Patients with severe visual field loss in either eye which is judged by the investigator.(19) Patients with current or history of use of any topical drug containing carbonic anhydrase inhibitor at screening visit.(20) Patients using any additional topical or systemic ocular hypotensive medication indicated for glaucoma or intraocular hypertension during the study.(21) Patients using corticosteroid medications administered by ocular or systemic route during the study.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1) Aihara Makoto 2)Fukuchi Takeo |
Organization
1)The University of Tokyo Hospital
2)Niigata University Medical& Dental hospital
Division name
1)Ophthalmology 2)Ophthalmology
Zip code
Address
1)7-3-1 Hongo,Bunkyo-ku,Tokyo,Japan 2)1-757 Asahimachi-dori, Chuo-ku,Niigata, Japan
TEL
1)03-3815-54112)025-227-2296
aihara-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakaguchi Hironari |
Organization
Alcon Japan Ltd.
Division name
PhaseIV Clinical & Regulatory Affairs, Japan
Zip code
Address
Toranomon Hills Mori Tower, 1-23-1 Minato-ku, Tokyo 105-6333 Japan
TEL
03-6899-5054
Homepage URL
Hironari.Sakaguchi@alcon.com
Sponsor or person
Institute
Alcon Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
木戸眼科クリニック（新潟県）、医療法人社団せき眼科医院（新潟県）、
医療法人社団ムラマツクリニック むらまつ眼科医院（静岡県）、
医療法人社団まつお眼科クリニック（東京都）、山下眼科クリニック（鹿児島県）、
竹内眼科医院（大阪府）、医療法人陽幸会うのき眼科（鹿児島県）、
うおぬま眼科（新潟県）、上田眼科（新潟県）、
医療法人社団 みすまるのさと会 アイローズクリニック（東京都）、
すずむら眼科（東京都）、医療法人社団研英会林眼科病院（福岡県）、
尾上眼科医院（大阪府）、やおえだ眼科（新潟県）、
医療法人 おざきメディカルアソシエイツ 尾崎眼科（宮崎県）、
医療法人明和会 宮田眼科病院（宮崎県）、
医療法人明和会 鹿児島宮田眼科（鹿児島県）、あんどう眼科クリニック（大阪府）、
国立大学法人新潟大学医歯学総合病院（新潟県）、アイケアクリニック（埼玉県）、
江口眼科病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=Makoto+Aihara+brinzolamide+dorzolamide
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
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2017 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
