Cataract patients with dry eye
Conditions
Interventions
Left eye Soft Santear,right eye Mucosta ophtalmic suspension UD2%,one time for one drop,four times a day,for 14 weeks
Left eye Mucosta ophthalmic suspention UD2%, right eye Soft Santier, one time for
Sponsors
The Ethical Review Board of Medical Association Ophthalmological Koseikai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Outpatient 2.Patient who plan the cataract surgery of both eyes 3.Patient who are diagnosed with dry eyes or probable dry eye according to the 2006 dry eye diagnostic criteria
Exclusion criteria
Exclusion criteria: 1.Patients complicated with any anterior segment disease other than dry eyes(including blepharitis, lagophthalmos,blepharospasm,and iritis ) (excluding past histories) 2. Patients unable to discontinue using contact lenses between the time of tests at the time of screening and the end of topical instillation of the study drug. 3. Patients with a lacrimal plug implanted or patients in whom a lacrimal opening plug dropped off within 3 months before the time of tests at the start of topical instillation. 4. Patients who perform a plan (hope) of the insertion of the Toric IOLs. 5. Patients with a history of ocular surface surgery within 12 months before tests at the start of topical instillation. 6. Patients with a severe eye disorder due to Stevens-Johnson syndrome or ocular pemphigoid. 7. Patients with hypersensitivity to any ingredient of the present study drug or reagent used in the present study. 8. Patients judged by the principal investigator/sub-investigator to be unable to be included in the study due to a previous or concurrent systemic disease. 9. Other patients judged by the principalinvestigator/sub-investigator to be not appropriate for safe implementation of the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wavefront aberration Fluorescein corneal conjunctival staining scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear film breakup time (BUT) Tear Meniscus(TMH) Schirmer test Symptoms | — |
Countries
Japan
Contacts
Public ContactAsami Nishimura
QOL RD Co.,Ltd Clinical Development Drug Division
Outcome results
None listed