UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019565 |
|---|---|
| Receipt number | R000022123 |
| Scientific Title | Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4% |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2018/10/31 17:44:27 |
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Basic information
Public title
Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4%
Acronym
Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4%(ROCKHY)
Scientific Title
Evaluation of conjunctival hyperemia induced by Glanatec ophthalmic solution 0.4%
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Atsuki Fukushima |
Organization
Kochi medical school hospital
Division name
Ophthalmology
Zip code
Address
Kohasu,Oko-cho,Nankoku 783-8505 Japan
TEL
088-880-2391
rock-hy@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emi Sakamoto |
Organization
Kochi medical school hospital
Division name
Ophthalmology
Zip code
Address
Kohasu,Oko-cho,Nankoku 783-8505 Japan
TEL
088-880-2391
Homepage URL
rock-hy@kochi-u.ac.jp
Sponsor or person
Institute
Kochi medical school hospital,ophthalmology
Institute
Department
Personal name
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)
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
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 |
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
| 2015 | Year | 08 | Month | 26 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022123
