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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026310
Receipt No. R000030215
Scientific Title Keratoconjunctivitis after cataract surgery and protective effect of rebamipide ocular solution.
Date of disclosure of the study information 2017/06/30
Last modified on 2017/02/26

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Basic information
Public title Keratoconjunctivitis after cataract surgery and protective effect of rebamipide ocular solution.
Acronym Post operative keratoconjunctivitis
Scientific Title Keratoconjunctivitis after cataract surgery and protective effect of rebamipide ocular solution.
Scientific Title:Acronym Post operative keratoconjunctivitis
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of protective effect of 2% rebamipide ocular solution on keratoconjunctivitis after cataract surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of goblet cell density of conjunctiva 1 month after the surgeries.
Key secondary outcomes Evaluation of BUT, anterior chamber inflammation and ocular surface disease index (OSDI) on 1 month and 2 month after the surgeries.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients received 0.1% diclofenac ocular solution without preservative three times daily one day after the surgery and continuedfor 28 days.
Interventions/Control_2 Patients received 0.1% diclofenac ocular solution without preservative three times daily and 2% rebamipide ocular solution four times daily one day after the surgery and continuedfor 28 days.
Interventions/Control_3 Patients received 0.1% betamethasone ocular solution without preservative three times daily one day after the surgery and continuedfor 28 days.
Interventions/Control_4 Patients received 0.1% betamethasone ocular solution without preservative three times daily and 2% rebamipide ocular solution four times daily one day after the surgery and continuedfor 28 days.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients underwent cataract surgery.
Key exclusion criteria Patients with diabetes mellitus, dry eye, glaucoma, history of glaucoma.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko Kato
Organization Mie University
Division name Department of Ophthalmology
Zip code
Address 2-174, Edobashi, Tsu-shi, Mie, Japan
TEL 059-231-5027
Email k-kato@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Matsubara
Organization Mie University
Division name Department of Ophthalomology
Zip code
Address 2-174, Edobashi, Tsu-shi, Mie, Japan
TEL 059-231-5027
Homepage URL
Email hmatsu@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University,Department of Ophthalmology
Institute
Department

Funding Source
Organization Mie University, Department of Ophthalomology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyake Eye Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 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 06 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2016 Year 12 Month 23 Day
Date of closure to data entry
2017 Year 02 Month 10 Day
Date trial data considered complete
2017 Year 02 Month 10 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 26 Day
Last modified on
2017 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030215

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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