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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017569
Receipt No. 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

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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
Email 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
Email Hironari.Sakaguchi@alcon.com

Sponsor
Institute Alcon Japan Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.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


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