UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5
Title of the study (Brief title)	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	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
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	Sakaguchi Hironari
Organization	Alcon Japan Ltd.
Division name	PhaseIV Clinical & Regulatory Affairs, Japan
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/?term=Makoto+Aihara+brinzolamide+dorzolamide
Results
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/icdr_e/ctr_view.cgi?recptno=R000020340