UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4%
Title of the study (Brief title)	Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4%(ROCKHY)
Region	Japan

Condition
Condition	Primary Open-Angle Glaucoma or Ocular Hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary purpose of this study is to evaluate disappearing time-point of conjunctival hyperemia induced by glanatec ophthalmic solution 0.4% in patients with glaucoma.The evaluation is based on clinical scoring system.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary purpose of this study is to evaluate disappearing time-point of conjunctival hyperemia induced by glanatec ophthalmic solution 0.4% in patients with glaucoma.The evaluation is based on clinical scoring system.
Key secondary outcomes	Additionally,the relationship between decrease of intraocular pressure and conjunctival hyperemia will also be evaluated. Furthermore, by using conjunctival hyperemia analyzing software, evaluation of conjunctival hyperemia will be more objective.

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	At the begining of trial,one drop of glanatec solution 0.4% will be instilled to the subjective eye.
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)Patients over 20years old with Primary Open-Angle Glaucoma or Ocular Hypertension who are not well controlled by a ophthalmic solution,and need addional treatment. 2)Proir treatment must be plostaglandin(PG)formulations and/or beta-bookers and/or Acetazolamide,the prescription number of times is once a day. 3)Patients have never been treated with glanatec ophthalmic solution. 4)Agreement is proven by a document signed by patient.
Key exclusion criteria	1)Patients having hypersensitivity against ripasujiru hydrochloride hydrate, Anhydrous dihydrogen phosphate sodium, Glycerine, Sodium hydroxide, Dark benzalconium chloride liquid 50. 2)Less than -12 dB of the MD value 3)Regarding pregnant women, Women whose terms are closed to and Lactating women, benefit is superior to dangerousness. 4)Secondary glaucoma, Exfoliation glaucoma,Angle closure glaucoma 5)Refract value: Less than-9.0D,More than +9.0D 6)Patients whose intra ocular pressure can not be measured by iCare Tonometer 7)Patients with traumatic injury. 8)Patients with ocular inflammation of anterior segment. 9)Patients who can not be applied for photo slit. 10)Patients having a history of the operation during the past 6 months. 11)Users of contact lenses 12)Patients who are decided not be suitable for this trial by doctors.
Target sample size	50

Research contact person
Name of lead principal investigator	Atsuki Fukushima
Organization	Kochi medical school hospital
Division name	Ophthalmology
Address	Kohasu,Oko-cho,Nankoku 783-8505 Japan
TEL	088-880-2391
Email	rock-hy@kochi-u.ac.jp

Public contact
Name of contact person	Emi Sakamoto
Organization	Kochi medical school hospital
Division name	Ophthalmology
Address	Kohasu,Oko-cho,Nankoku 783-8505 Japan
TEL	088-880-2391
Homepage URL
Email	rock-hy@kochi-u.ac.jp

Sponsor
Institute	Kochi medical school hospital,ophthalmology
Institute
Department

Funding Source
Organization	Kowa company.Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	高知大学医学部附属病院（高知県）、広島大学病院（広島県）、ツカザキ病院（兵庫県）/Kochi medical school hospital(Kochi),Hirosima University Hospital(Hiroshima) ,Tsukazaki Hospital(Hyogo)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 26 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 06 Month 30 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 30 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022123