UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of lutein in high myopic patients
Acronym	Lutein and high myopia
Scientific Title	The effectiveness of lutein in high myopic patients
Scientific Title:Acronym	Lutein and high myopia
Region	Japan

Condition
Condition	high myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study if orally administration of lutein could improve visual functions such as visual acuity, ERG, concentration of macular pigmentation, contrast sensitivity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The study of contrast sensitivity at baseline, 3-month and 6-month from baseline.
Key secondary outcomes	The study of visual acuity, concentration of macular pigmentation and ERG at baseline, 3-month and 6-month from baseline.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Lutein administration group . Oral administration of Lutein 1capsule (20mg/capsule ) per day for 6 months
Interventions/Control_2	Placebo administration group . Oral administration of sunflower oil 1capsule (180mg/capsule ) per day for 6 months
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	Not applicable
Gender	Male and Female
Key inclusion criteria	high myopia patients
Key exclusion criteria	Patients who have serious retinal diseases such as glaucoma, age related macular degeneration and bleeding. Patients who have severe kidney disease , heart failure and hepatitis. People who have taken administration of lutein in 6 months.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kyoko Middle name Last name Ohno
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Zip code	1138519
Address	0358035302
TEL	0358035302
Email	k.ohno.oph@tmd.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Yoshida
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Zip code	1138519
Address	Bunkyoku Yushida 1-5-45
TEL	0358035302
Homepage URL
Email	takec.oph@tmd.ac.jp

Sponsor
Institute	Department of Ophthalmology, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Santen pharmaceutical company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	N/A
Address	Tokyo Medical and Dental University
Tel	0338136111
Email	syomu1.adm@tmd.ac.jp

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 01 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	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 09 Month 21 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 12 Day
Last modified on	2020 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029418