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

JRCT ID: jRCT1080222777

Registered date:03/03/2015

Basic Information

• Health condition(s) or Problem(s) studied: Dry eye
• Date of first enrollment: 03/03/2015
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 material : Instillation, 6times/day for 4weeks

control material(s)
Generic name etc : placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Instillation, 6times/day for 4weeks

Outcome(s)

• Primary Outcome: 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 Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Lion Corporation
• Secondary ID(s): JapicCTI-152829