UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011397 |
|---|---|
| Receipt number | 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 16:16:38 |
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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
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
motoko326@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013344
