UMIN-CTR Clinical Trial

Public title

Study of the influence of instillation period of perioperative antibacterial opthalmic solution on human conjunctival flora

Acronym

Study of the influence of instillation period of perioperative antibacterial opthalmic solution on human conjunctival flora

Scientific Title

Study of the influence of instillation period of perioperative antibacterial opthalmic solution on human conjunctival flora

Scientific Title:Acronym

Study of the influence of instillation period of perioperative antibacterial opthalmic solution on human conjunctival flora

Region

Japan

Condition

Patient underwent cataract surgery

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the influence of levofloxacin 1.5% eye drops on conjunctival flora of the patients after between one week and after one month period after cataract surgery

Basic objectives2

Others

Basic objectives -Others

To investigate the change of bacteria isolates from the onjunctiva sac with antibiotics susceptibility after post-operative antibiotic instillation.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Antibiotic susceptibility of isolated bacteria
(pre operation,end of instillation, post 1 3 6 9 12 months)

Key secondary outcomes

Prevalenced bacterialin species in the conjunctiva flora.
Change of antibiotic resistant.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Topical instillation: levofloxacin 1.5% ophthalmic solution 4 times per day
Administration period after cataract surgery: One week, 50 patients, 50eyes.

Interventions/Control_2

Topical instillation: levofloxacin 1.5% ophthalmic solution 4 times per day
Administration period after cataract surgery: One month, 50 patients 50 eyes.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with bacteria examination within three months of cataract surgery.
2) Patients to obtain the written consent

Key exclusion criteria

1) Patients with a history of antibiotics prescription within three months prior to the study.
2) Patients with a history of hypersensitivity or severe adverse effects by fluoroquinolones.
3) Glaucoma patients treated with ophthalmic solutions
4) Patients under steroid ophthalmic solutions
5) Patients under immunosuppressive therapy
6) Patients suspecting to be any infectious ocular diseases.
7) Patients whom investigators considered not to be are eligible.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kazunori MIYATA

Organization

Miyata Eye Hospital

Division name

Miyata Eye Hospital

Zip code

Address

6-3 Kurahara Miyakonojo Miyazaki 885-0051

TEL

0986-22-1441

Email

miyata@miyata-med.ne.jp

Name of contact person

1st name
Middle name
Last name	Ryohei NEJIMA

Organization

Miyata Eye Hospital

Division name

Miyata Eye Hospital

Zip code

Address

6-3 Kurahara Miyakonojo Miyazaki 885-0051

TEL

0986-22-1441

Homepage URL

Email

nejima@miyata-med.ne.jp

Institute

Miyata Eye Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Santen Pharmaceutical Co., Ltd.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

宮田眼科病院（宮崎県）

Date of disclosure of the study information

2016

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

MICs of LVFX against S. epidermidis increased during LVFX 1.5% administration compared to Pre levels in both groups, and showed a declining trend after administration completion. However, by 3 months, MICs in the 1M group were approximately twice those in the 1W group. Antibiotic sensitivity testing at Pre, 0D, and 3M time-points showed susceptibility of 73.6%, 20.2%, and 38.5% strains, respectively, in the 1W group, compared with 63.0%, 0.0%, and 19.3% strains, respectively, in the 1M group. The results indicate that from 0D to 3M, susceptible strains were approximately 20% lower in the 1M Group than in the 1W group.

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

03

Month

25

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

24

Day

Last modified on

2016

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024409