The dry eye patients complicated with Sjogren'
Conditions
Interventions
Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes
Soft Santear, q.i.d. for 4weeks
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ambulatory care patients 2. Patients who have been diagnosed with dry eye in the 2006 dry eye diagnostic criteria. 3. Screening starting examination, patients with symptoms of eye associated with dry eye is expressed earlier than 12 months. 4. In the eye drops at the start of testing, dry eye-related eye symptoms (foreign body sensation, dryness, eye pain, photophobia, blurred vision, eye strain) of any of the score is greater than or equal to 50mm patient 5. .Patients following conditions are met in 5. instillation start time of inspection a) score of fluorescein corneal staining is 3 or more (up to 15) b) score of fluorescein conjunctival staining is 4 or more (up to 18) 6. In the screening at the start of testing, patient corrected visual acuity is greater than or equal to 0.2 in both eyes.
Exclusion criteria
Exclusion criteria: 1.Patients merged the anterior segment of the eye diseases other than dry eye including blepharitis, lagophthalmos, the blepharospasm and iritis. 2.Patients screening at the start of eye drops other than study drug until the time of the study drug instillation Exit from the test patients who cannot stop the use is expected. 3.Patients who cannot discontinue use of contact lenses during the study. 4.Patients punctal plug dropped out within three months of the insert the punctal plug and are patient or eye drops at the start of testing. Patients with a history of surgical punctal closure surgery. 5.Patients with steroid eye drops within two weeks of screening at the start of inspection. 6.Patients within 12 months of the test at the start of the inspection of surgical history of ocular surface. Patients with intraocular surgical history within three months. 7.Stevens-Johnson syndrome, patients with advanced eye damage due to ocular pemphigoid. 8.Patients with hypersensitivity to test drug ingredients and this testing of the present study drug. 9.Patients who are judged to be ineligible for the study for complications and/or history of systemic disease. 10.Patients with severe conjunctival laxa Grade3 11.Patients who are considered to be inapproriate by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein staining score Symptoms Tear film breakup time Oxidative stress markers in tears The time of data totalization/analysis will be at baseline, after 4 weeks, or at discontinuation. | — |
Countries
Japan
Contacts
Public ContactAkira Nagai
APO PLUS STATION Co.,Ltd Clinical Study Dept. CRO Business Div.
Outcome results
None listed