NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-152829

Registered date:

XED-60 in the treatment of dry eye, Phase2 study.

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedDry eye
Date of first enrollment11/3/2015
Target sample size60
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : XED-60 Dosage And administration of the intervention : Instillation, 6times/day for 4weeks Control intervention name : placebo Dosage And administration of the control intervention : Instillation, 6times/day for 4weeks

Outcome(s)

Primary OutcomeThe 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 OutcomeThe 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).

Key inclusion & exclusion criteria

Age minimum15
Age maximum
GenderBOTH
Include 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
Exclude 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

Related Information

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Name Lion Corporation Consumer Service Center
Address 0120-813-752
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