UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026310 |
|---|---|
| Receipt number | 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 00:07:43 |
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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
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
hmatsu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University,Department of Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030215
