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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011397
Receipt No. R000013344
Scientific Title A randomized study comparing topical rebamipide with artificial tears in the treatment of dry eye with contact lens wearers
Date of disclosure of the study information 2013/08/07
Last modified on 2016/08/10

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Basic information
Public title A randomized study comparing topical rebamipide with artificial tears in the treatment of dry eye with contact lens wearers
Acronym A randomized study comparing topical rebamipide with artificial tears in the treatment of dry eye with contact lens wearers
Scientific Title A randomized study comparing topical rebamipide with artificial tears in the treatment of dry eye with contact lens wearers
Scientific Title:Acronym A randomized study comparing topical rebamipide with artificial tears in the treatment of dry eye with contact lens wearers
Region
Japan

Condition
Condition dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of rebamipide ophthalmic suspension compared with artificial tears for dry eye patients with contact lens wearers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dry eye parameters (subjective and objective findings)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rebamipide ophthalmic suspension
Interventions/Control_2 artificial tears
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
65 years-old >=
Gender Male and Female
Key inclusion criteria dry eye patients
soft contact lens wearers
Key exclusion criteria People with anterior segment eye diseases except dry eye disease
Patients with severe posterior segment eye diseases
Patients who use steroid, anti-inflammatory and immune suppression drugs
Patients who take any anti-oxidant supplements.
Patients with serious systemic diseases
Patients who had any ocular surgery within 12 month prior to signing the informed consent
Patients who had any punctual occlusion within 1 month prior to signing the informed consent
People whom the investigator or the subinvestigators consider to be ineligible for the intervention therapy in any other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoko Kawashima
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0353633866
Email motoko326@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Motoko Kawashima
Organization Keio University School of Medicine
Division name Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0353633866
Homepage URL
Email motoko326@gmail.com

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 07 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
2013 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 10 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
2013 Year 08 Month 07 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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