diabetes with an anterior-epithelium-of-cornea obstacle
Conditions
Interventions
DIQUAS ophthalmic solution
Hyalein ophthalmic solution
Soft Santear
Sponsors
Tokyo Women's Medical University School of Medicine
Nihon University Itabashi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patients aged 20 and over in the time of consent acquisition. 2.The patient who the amount fall of tear fluid secretion was permitted to by the Schirmer examination (5mm or less), and was permitted the anterior-epithelium-of-cornea obstacle by intravital staining (a fluorescein examination or a rose bengal examination). 3.The patients whose the HbA1c values is 6.5% or more (NGSP value) at the time of the start of clinical study or within 1 month of the start. 4.After being given to sufficient explanation in the participation in this research and understanding the main point and the details of this research enough -- a patient -- the patient by whom the document consent by the free intention of the person himself/herself was got.
Exclusion criteria
Exclusion criteria: 1.The user of a contact lens (used within one week or the existing patient who is going to use a contact lens during medical treatment observation) 2.The patient who has the past of cornea refractive surgery. 3.The patient currently diagnosed as meibomian gland dysfunction. 4.The patient suffered from eye infection or a serious allergic conjunctival disease. 5.The patient currently diagnosed as the cicatricial angle conjunctival disease (eye pemphigoid, and Stevens-Johnson syndrome and alkali externally caused injury are included). 6.The patient who has the past of an inner eye operation (laser surgery is included) within three months before an observation start. 7.The patient who was continuing the medical treatment (a punctum plug insertion way, a surgical punctum closing way, etc.) aiming at the blockade of punctum before the observation term start till less than one month. 8.The patient who is performing dry eye auxiliary medical treatment which has on pharmacometrics, such as glasses for dry eye protection. 9.The patient who has eyeblink insufficiency. 10.The patient who has a schedule which adds an applying- ophthalmic solution during exam. 11.The patient with the schedule which uses the medicine (treatment) provided in the regulation about a concomitant drug (treatment) during exam. 12.The patient who had complications of the heart, liver, the kidney, blood dyscrasia, and others, and was judged to be unsuitable on pharmacometrics. 13.The patient who there is under pregnancy and breast-feeding or a possibility of having become pregnant, or wishes to become pregnant within one month after the scheduled end of an observation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change before and behind the medical treatment of the Schirmer examination I method | — |
Countries
Japan
Contacts
Public ContactMakiko Katagiri, M.D.
Tokyo Women's Medical University School of Medicine Diabetes Center Ophthalmology
Outcome results
None listed