Unique ID issued by UMIN | UMIN000009071 |
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Receipt number | R000010646 |
Scientific Title | Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study). |
Date of disclosure of the study information | 2012/11/01 |
Last modified on | 2014/11/12 14:07:30 |
Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Japan |
Dry eye
Ophthalmology |
Others
NO
To make a comparative review of efficacy, the changes of subjective symptom and safety of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution.
Safety,Efficacy
Symptoms and Tear film breakup time
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Diquafosol sodium ophthalmic solution
Sodium hyaluronate ophthalmic solution
20 | years-old | <= |
Not applicable |
Male and Female
1) 20 years old or older.
2) female or male.
3) Schirmer test I below 5 mm in 5 minutes or BUT below 5 seconds.
4)General state score of symptoms is 4 greater, and degree score is 3 greater in at least more than 1 item within ophthalmic symptoms items.
5)Fluorescein staining score less than 3.
1) Patients who use artificial tears eyedrops within 2 weeks before a study starts.
2) Patients who need to use eyedrops other than test drugs during a study .
3) Patients who have anatomically and functionally abnormal eyelid.
4) Patients who develop allergic conjunctivitis disease requiring treatment when a study starts.
5) Patients who underwent ophthalmic surgery within 3 months before study starts ( however LASIK within 6 months).
6) Patient who have a previous history of treatment intended to become obstructed lacrimal puncta.
7) Patients who have a previous allergy to drugs that they use during a study.
200
1st name | |
Middle name | |
Last name | Yuichi Ohashi |
Ehime University
Department of Ophthalmology
Shizugawa touonshi, Ehimeken
089-960-5361
ohashi@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Shiraishi |
Ehime University
Department of Ophthalmology
Shizugawa touonshi, Ehimeken
089-960-5361
shiraia@m.ehime-u.ac.jp
Ehime University
Santen pharmaceutical company
Profit organization
Japan
NO
2012 | Year | 11 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 11 | Day |
2012 | Year | 10 | Month | 12 | Day |
2012 | Year | 10 | Month | 09 | Day |
2014 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010646
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