UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010975 |
|---|---|
| Receipt number | R000012845 |
| Scientific Title | Effects of 3% diquafosol sodium ophthalmic solution on visual function in patient with dry eye wearing contact lens. |
| Date of disclosure of the study information | 2013/06/30 |
| Last modified on | 2013/06/15 13:44:13 |
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Basic information
Public title
Effects of 3% diquafosol sodium ophthalmic solution on visual function in patient with dry eye wearing contact lens.
Acronym
Effects of 3% diquafosol sodium ophthalmic solution on visual function in patient with dry eye wearing contact lens.
Scientific Title
Effects of 3% diquafosol sodium ophthalmic solution on visual function in patient with dry eye wearing contact lens.
Scientific Title:Acronym
Effects of 3% diquafosol sodium ophthalmic solution on visual function in patient with dry eye wearing contact lens.
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o investigate the efficacy of 4 weeks administration of 3% diquafosol sodium ophthalmic solution on visual function in patients with dry eye who wear contact lenses routinely and complain decreased visual performance. TO investigate the change of subjective and objective symptoms associated with dry eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of visual function
Change of subjective symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Instillation of 3% diquafosol sodium ophthalmic solution, 6 times daily for 4 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
At time of informed consent
1) 20 years old and older.
2) Wearing contact lenses routinely.
At time of starting administration
1) Diagnosed patients with dry eye or dry eye suspects based on dry eye diagnostic criteria (2006).
2) Patients with wearing 1 day acuvue moist; routinely for 1week or longer and complaining decreased visual performance.
Key exclusion criteria
1) History of administered diquafosol sodium ophthalmic solution and/or rebamipide ophthalmic solution within one week before start of study.
2) Anatomically and/or functionally abnormal eyelid. (ex. eyelid closure abnormality)
3) History of ophthalmic surgery (including laser therapy) within 3 months before start of study.
4) History of occluding punctum. (ex. punctal plug or a punctal closing surgery)
5) Presence of a hypersensitivity to drugs scheduled to be used. (ex. diquafosol sodium, fluorescein, oxybuprocaine hydrochloride)
6) Presence of any other medical concern that may affect the accurate efficacy assessment or ensuring safety.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Toda |
Organization
Minamiaoyama Eye Clinic Tokyo
Division name
Director
Zip code
Address
3-3-11 Kita-aoyama Minato-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Minamiaoyama Eye Clinic Tokyo
Division name
Director
Zip code
Address
TEL
03-5772-1440
Homepage URL
Sponsor or person
Institute
Minamiaoyama Eye Clinic Tokyo
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 12 | 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
| 2013 | Year | 06 | Month | 15 | Day |
Last modified on
| 2013 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012845
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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