UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Factors related to dry eye after ocular surgery and its treatment.
Title of the study (Brief title)	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	Yu Monden
Organization	Kurume University School of Medicine
Division name	Department of Ophthalmology
Address	67 Asahi-machi, Kurume 830-0011, Japan.
TEL	0942-31-7574
Email	you@med.kurume-u.ac.jp

Public contact
Name of contact person	Yu Monden
Organization	Kurume University School of Medicine
Division name	Department of Ophthalmology
Address	67 Asahi-machi, Kurume 830-0011, Japan.
TEL	0942-31-7574
Homepage URL
Email	kurumeye@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015772