UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Factors affecting Eye Drop Instillation in Glaucoma Patients with visual field defect
Title of the study (Brief title)	Factors affecting Eye Drop Instillation in Glaucoma Patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate the success rate of eye drop instillation in glaucoma patients with visual field defect(VFD) as well as non-glaucoma volunteers. Factors that may affecting the success rate of eye drop instillation was also evaluated.
Basic objectives2	Others
Basic objectives -Others	Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	20 years-old <
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Glaucoma patients or non-glaucoma volunteers
Key exclusion criteria	Subjects were excluded if they had a history of active ocular inflammation such as recurrent uveitis, scleritis, or corneal herpes as well as if they had ocular injuries, intraocular surgery, or laser surgery in advance of 3 months of the present study.
Target sample size	200

Research contact person
Name of lead principal investigator	Tomoko Naito
Organization	Okayama University Medical School Hospital
Division name	Ophthalmology
Address	2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8558, JAPAN
TEL	086-235-7297
Email	tomokoum@gmail.com

Public contact
Name of contact person	Tomoko Naito
Organization	Okayama University Medical School Hospital
Division name	Ophthalmology
Address	2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8558, JAPAN
TEL	086-235-7297
Homepage URL
Email	tomokoum@gmail.com

Sponsor
Institute	Okayama University Medical School Hospital
Institute
Department

Funding Source
Organization	Okayama University Medical School Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 26 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 08 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Open angle glaucoma patients with VFD as well as non-glaucoma volunteers were asked (requested) to video recording their procedure (maneuver) of eye drop instillation using a 5 mL plastic bottle of artificial tear solution. Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators. A variety of factors relating to success rate of eye drop instillation such as VFD and clinical characteristics were also analyzed applying the multivariable logistic regression .

Management information
Registered date	2017 Year 04 Month 26 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031103