UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013501 |
|---|---|
| Receipt number | R000015772 |
| Scientific Title | Factors related to dry eye after ocular surgery and its treatment. |
| Date of disclosure of the study information | 2014/03/26 |
| Last modified on | 2018/12/22 09:32:28 |
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Basic information
Public title
Factors related to dry eye after ocular surgery and its treatment.
Acronym
Dry eye after cataract surgery.
Scientific Title
Factors related to dry eye after ocular surgery and its treatment.
Scientific Title:Acronym
Dry eye after cataract surgery.
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference in developing dry eye after cataract surgery between two topical nonsteroidal anti-inflammatory drugs and the effect of rebamipide eye drops on dry eye onset.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tear film break up time measured with OCULUS Keratograph 5M and with stopwatch. Goblet cell density by conjunctival impression cytology.
Key secondary outcomes
Dry eye symptom score, Schirmer I test, fluorescein staining, lissamine green staining, and corneal sensitivity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levofloxacin eye drops
betamethasone eye drops
nepafenac eye drops
Interventions/Control_2
levofloxacin eye drops
betamethasone eye drops
bromfenac eye drops
Interventions/Control_3
levofloxacin eye drops
betamethasone eye drops
bromfenac eye drops
rebamipide eye drops
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients before cataract surgery.
Key exclusion criteria
Patients with dry eye before cataract surgery.
Patients with diabetes mellitus.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Monden |
Organization
Kurume University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942-31-7574
you@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Monden |
Organization
Kurume University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942-31-7574
Homepage URL
kurumeye@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015772
