Dry eye
Conditions
Interventions
investigational material(s)
Generic name etc : OPH
INN of investigational material :
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material :
Sponsors
Ophtecs Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatient 20 years of age or older. Outpatients who have been given a definite diagnosis of dry eye according to the Diagnostic Criteria by the Dry Eye Society (1995) .
Exclusion criteria
Exclusion criteria: Patients with Stevens-Johnson syndrome or ocular pemphigoid Patients with keratoconjunctival chemical or thermal injury Patients with any ocular surface disease other than dry eye (e.g. allergic conjunctivitis) requiring treatment Any anatomical and functional eyelid abnormality (e.g. insufficient eyelid closure) History of an allogeneic hematopoietic stem cell transplantation History of intraocular surgery (including laser therapy) within 3 months prior to informed consent History of a punctal plug surgery and/or punctal closing surgery (excluding no history of the surgeries in the study eye, loss of punctal plug or puncta opening at the time of informed consent) Patients who will/must use any eye drops for dry eye treatment other than the study drug, ophthalmic drug, prohibited concomitant drug or therapy during the study period Patients who are pregnant or breastfeeding, have a possibility of pregnancy or are willing to pregnant during the study period Patients who need to wear contact lenses Patients who had participated any other trial within the past 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein staining score The change in fluorescein staining scores (difference in scores between Week 0 and 4) in the OPH group and placebo group will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rose bengal staining score, subjective symptoms, and tear film break up time The changes in rose bengal staining score, subjective symptoms, and tear film break up time (difference in scores between Week 0 and 4) in the OPH group and placebo group will be calculated. | — |
Outcome results
None listed