Dry eye
Conditions
Interventions
investigational material(s)
Generic name etc : XED-60
INN of investigational material :
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational materia
Sponsors
Lion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males or Females (2) 15years old or older (3) Out patient (4) Meet the diagnostic criteria (Definition and Diagnosis of Dry Eye 2006) of the Japanese Dry Eye Research group (5) Dryness score of dry eye-related ocular symptoms 2 point or over
Exclusion criteria
Exclusion criteria: (1) Stevens-Johnson syndrome and ocular pemphigoid (2) Chemical or thermal burns (3) Other ocular diseases (4) Allogeneic heamatopoietic stem cell transplantation (5) Any history of ocular surgery within 3 months (6) Refractive corneal surgery (7) Patient with punctal plug (8) Female patients who are pregnant, possibly pregnant or breast feeding (9) Known hypersensitivity to any component of the study drug or procedual medications (10) Glaucoma patient (11) Anticipated use of contact lens during the study (12) Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study (13) Any systemic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in dry eye symptom score (dryness), fluorescein and rose bengal staining scores from baseline at the 4-week endpoint (last observation carried forward). | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in subjective dry eye symptom score (11 parameters: foreign body sensation, photophobia, itching, eye pain, heaviness, blurred vision, eye fatigue, eye discomfort, eye discharge, hyperemia and lacrimation), BUT and Schirmer's test result from baseline at the 4-week endpoint (last observation carried forward). | — |
Outcome results
None listed