UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Acronym	The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Scientific Title	The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Scientific Title:Acronym	The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Region	Japan

Condition
Condition	ocular hypertension and glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva before and one year after the addition of brimonidine.
Key secondary outcomes	1. The transition of the species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva. 2. The transition of the expression of gene of qacA/B, C/D from the isolated staphylococcus epidermidis. 3. The antibacterial effect of 0.1% brimonidine on the isolated staphylococcus epidermidis.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	People who have been treated with prostaglandin analog alone for ocular hypertension or glaucoma and are necessary to add brimonidine.
Key exclusion criteria	1. People who have used intraocular pressure lowering drugs other than prostaglandin analog. 2. The use of antibacterial drug within three months from the initiation of brimonidine. 3. The use of eye drops with BAC within three months from the initiation of brimonidine. 4. People who have active ocular infection. 5. People who have severe underlying medical problems or complications. 6. People who are judged as improper for this study from the investigators.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Iwasaki
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Zip code	8850051
Address	6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
TEL	0986-22-1441
Email	tkyiwasaki@gmail.com

Public contact
Name of contact person	1st name Takuya Middle name Last name Iwasaki
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Zip code	8850051
Address	6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
TEL	0986-22-1441
Homepage URL
Email	tkyiwasaki@gmail.com

Sponsor
Institute	Miyata Eye Hospital
Institute
Department

Funding Source
Organization	SENJU PHARMACEUTICAL CO., 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	Miyata Eye hospital
Address	6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
Tel	0986-22-1441
Email	ushihama@miyata-med.ne.jp

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

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 12 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	Open public recruiting
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 01 Month 24 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva before, 3 months, 6 months, 9 months and one year after the addition of brimonidine were examined.

Management information
Registered date	2019 Year 04 Month 11 Day
Last modified on	2020 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041562