Dry eye
Conditions
Interventions
investigational material(s)
Generic name etc : SI-01
INN of investigational material : -
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational materia
Sponsors
IDD, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who provide written voluntary consent to participate in this study; (2) Patients 20 years or more of age at the time of consent; (3) Patients who receive a diagnosis of dry eye according to the diagnostic criteria for dry eye (2016) at the start of screening (Visit 1); (4) Patients who have a (tear film) break-up time (BUT) of 5 seconds or lower in at least one eye at the start of screening (Visit 1) and at the start of ocular instillation treatment (Visit 3) (the same eye must be tested at Visits 1 and 3); (5) Patients who have a symptom (Ocular Surface Disease Index [OSDI]) score of 13 or more at the start of screening (Visit 1) and at the start of ocular instillation treatment (Visit 3); (6) Patients who have a fluorescein staining score of 3 or more in at least one eye at the start of screening (Visit 1) and at the start of ocular instillation treatment (Visit 3) (the same eye must be tested at Visits 1 and 3); and (7) Patients who consent to use medically approved contraceptive methods during the study period. [Medically approved contraceptive methods are defined as combined use of two methods from the following methods or sexual abstinence: condom, oral contraceptive, intrauterine device, contraceptive diaphragm, spermicide, cervical cap, or contraceptive sponge.]
Exclusion criteria
Exclusion criteria: (1) Patients with any anterior segment ocular disease other than dry eye (including blepharitis and allergic conjunctival disease); (2) Patients with autoimmune diseases, including atopic dermatitis; (3) Patients with severe eye disorder, including Stevens-Johnson syndrome and ocular pemphigoid; (4) Patients who are currently on continuous ocular instillation treatment for any ophthalmologic disease other than dry eye; (5) Patients who cannot discontinue the use of, or are expected to use, ophthalmic drugs during the study period; (6) Patients who require the use of contact lenses during the study period; (7) Patients who have undergone surgery on the ocular surface or surgery inside the eye (including corneal refractive surgery and cataract surgery) within 1 month before consent; (8) Patients who have undergone corneal refractive surgery other than LASIK or SMILE; (9) Patients who have undergone lacrimal plug insertion and/or surgical punctal occlusion; (10) Patients with concurrent or a history of cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, respiratory, or neuropsychiatric diseases who are judged by the investigator or subinvestigator to be unsuitable as a subject in this study because of the disease that may affect the results of this study; however, patients with allergic disease may be included in this study if they do not seem to present with symptoms during participation in this study and the investigator or subinvestigator judges that there will be no problem in including them in this study. (11) Patients with a history (or concurrent signs) of drug allergy; (12) Patients who have participated in another trial and received an investigational drug within 3 months before administration of SI-01; (13) Pregnant, possibly pregnant, or breastfeeding women; (14) Patients who are unwilling or unable to comply with subject's responsibilities specified in the protocol; or (15) Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in this study for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy (1) Tear film break-up time (BUT) (2) Subjective symptoms: Ocular Surface Disease Index (OSDI) and Visual Analog Scale (VAS) (3) Fluorescein staining score | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics (1) Efficacy 1) Lissamine Green staining score 2) Corneal sensitivity test (using Cochet-Bonnet aesthesiometer) 3) Schirmer's test (Schirmer I test) (2) Exploratory 1) Corneal subbasal nerve parameters on laser scanning in vivo confocal microscopy (IVCM) 2) Proteins in lacrimal fluid (3) Safety 1) Adverse events 2) Intraocular pressure, visual acuity, slit-lamp microscopy, and funduscopy 3) Clinical laboratory tests (4) Pharmacokinetics 1) Plasma concentrations | — |
Countries
Japan
Outcome results
None listed