Dry eye
Conditions
Interventions
Mucosta ophthalmic suspension UD2% Dosage: 1 drop, 4 times daily
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients in whom dry eye has been diagnosed based on "2006 Diagnostic Criteria for Dry Eye" 2.Type of patient: Outpatient 3.At least 20 years of age at the time of informed consent obtained 4.Dry eye-related ocular symptom score of >=2 for either one of foreign body sensation; dryness; photophobia; ocular pain; and blurred vision 5.Patients who meet the following conditions in the same eye 1)Corneal fluorescein staining score of >=3 2)Conjunctival fluorescein staining score of >=4 3)Schirmer's test value of <=5 mm at 5 minutes under anesthesia
Exclusion criteria
Exclusion criteria: 1.Patients with any anterior segment eye disease such as blepharitis, lagophthalmos, blepharospasm, and iritis, except dry eye (Patients with past history of those diseases are acceptable.) 2.Patients to whom any ophthalmic drops (all prescription and OCT drugs included) are not able to be discontinued, or expected to be used from the start of the screening until the end of the study period. (Soft santear is acceptable during the screening period.) 3.Patients who cannot discontinue the use of contact lenses from the start of the screening until the end of the study period 4.Patients with punctal plugs 5.Patients who underwent any surgery on the ocular surface within 12 months or intraocular surgery within 3 months prior to the start of the screening 6.Patients with severe ocular disorder due to Stevens-Johnson syndrome or ocular pemphigoid 7.Patients who are pregnant, lactating, or may be pregnant 8.Patients with hypersensitivity reaction to components of the study drug or test agents used in this study 9.Patients whom investigatoror sub-investigatorconsidered not to be able to include the study because of prior or complicated systemic disease 10.Patients participating in another clinical study or trial 11.Others who areconsidered inappropriate for the study by investigatoror sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Dry eye-related ocular symptoms score -Cytokine and chemokine levels in tears -Tear film breakup time -Fluorescein corneal staining score -Lissamine green conjunctival staining score -Lid wiper epitheliopathy grading -Corneal sensation -Structural score of conjunctival epithelial cell -Goblet cell density -Corneal epithelial cell density, mean individual epithelial cell area (MIECA )and N/C ratio -Corneal neural density | — |
Countries
Japan
Contacts
Public ContactDogru Murat
Tokyo Dental College Ichikawa General Hospital Department of Ophthalmology
Outcome results
None listed